51 Manufacturing Qa jobs in Ireland
Manufacturing Engineer/Quality Engineer
Clonmel, Munster
Abbott
Posted 28 days ago
Job Viewed
Job Description
**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia, and other serious vascular conditions.
**We are currently looking for Manufacturing Engineers and Quality Engineers to join our modern site in Clonmel.**
**This is how you will make a difference:**
As a Manufacturing Engineer, you will be responsible for engineering support of manufacturing operations, which will involve key engineering metric management and process optimization activities including Manufacturing Yield improvement, product quality monitoring, lean manufacturing design and material/equipment/process troubleshooting using continuous improvement tools and methodology. Working as part of the operations support team, the manufacturing engineer will liaise with operations, quality, R&D and materials & purchasing departments to ensure quality and efficient manufacturing operations.
**Main responsibilities**
+ Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
+ Prepares reports, publishes, and makes presentations to communicate findings.
+ Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
+ Understands engineering principles theories, concepts, practices and techniques.
+ Understands the business needs of the company, and has knowledge of the customer needs of our business.
+ Understands the business cycle and foresight of emerging technologies trends.
+ Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees.
+ May lead a project team, determining goals and objectives for the projects.
+ Mentors employees by sharing technical expertise and providing feedback and guidance.
+ Interacts cross functionally and with internal and external customers.
+ Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
+ Acts as a spokesperson to customers on business unit current and future capabilities.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
**Experience, Education and Skills Required - Manufacturing Engineer:**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.2+ years of related work experience, or an equivalent combination of education and work experience.
+ Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function.
+ Learns to use professional concepts and company policies and procedures to solve routine problems.
+ Developing a network of internal resources to facilitate completion of tasks.
**JOB DESCRIPTION:**
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**Purpose Statement:**
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Shift Role: 2-cycle shift (8-16:30 and 16:30-00:30)
**Key Responsibilities - Quality Engineer:**
1. Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
2. Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
4. Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
**Education & Job Skills - Quality Engineer**
+ (Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
+ (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule.
+ (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
+ (Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia, and other serious vascular conditions.
**We are currently looking for Manufacturing Engineers and Quality Engineers to join our modern site in Clonmel.**
**This is how you will make a difference:**
As a Manufacturing Engineer, you will be responsible for engineering support of manufacturing operations, which will involve key engineering metric management and process optimization activities including Manufacturing Yield improvement, product quality monitoring, lean manufacturing design and material/equipment/process troubleshooting using continuous improvement tools and methodology. Working as part of the operations support team, the manufacturing engineer will liaise with operations, quality, R&D and materials & purchasing departments to ensure quality and efficient manufacturing operations.
**Main responsibilities**
+ Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
+ Prepares reports, publishes, and makes presentations to communicate findings.
+ Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
+ Understands engineering principles theories, concepts, practices and techniques.
+ Understands the business needs of the company, and has knowledge of the customer needs of our business.
+ Understands the business cycle and foresight of emerging technologies trends.
+ Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees.
+ May lead a project team, determining goals and objectives for the projects.
+ Mentors employees by sharing technical expertise and providing feedback and guidance.
+ Interacts cross functionally and with internal and external customers.
+ Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
+ Acts as a spokesperson to customers on business unit current and future capabilities.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
**Experience, Education and Skills Required - Manufacturing Engineer:**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.2+ years of related work experience, or an equivalent combination of education and work experience.
+ Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function.
+ Learns to use professional concepts and company policies and procedures to solve routine problems.
+ Developing a network of internal resources to facilitate completion of tasks.
**JOB DESCRIPTION:**
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**Purpose Statement:**
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Shift Role: 2-cycle shift (8-16:30 and 16:30-00:30)
**Key Responsibilities - Quality Engineer:**
1. Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
2. Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
4. Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
**Education & Job Skills - Quality Engineer**
+ (Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
+ (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule.
+ (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
+ (Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
0
Quality/manufacturing engineer
Galway, Connacht
Oxford Global Resources
Posted 1 day ago
Job Viewed
Job Description
Are you a Quality/Manufacturing engineer looking for a new opportunity? Don't hesitate and apply today! PROJECT DESCRIPTION We are seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483. These roles will focus on manufacturing process validation, quality system updates, and documentation remediation. Consultants will be based onsite and work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready. The project will involve tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes. Consultants must be able to take a problem statement through to a compliant solution, collaborating cross-functionally across Quality, Manufacturing, and Regulatory teams. PROJECT DESCRIPTIONPartner with process owners on the floor to capture and remediate issues.Support process validation (IQ/OQ/PQ) and documentation updates.Drive CAPA/NCR closure and implement compliant solutions.Provide technical writing for quality and manufacturing documents.Collaborate cross-functionally to ensure regulatory compliance. CONSULTANT RESPONSIBILITIESEngineering or Quality degree with 5-10 years' med-tech experience.Background in remediation, process validation, CAPA, NCRs.Strong technical writing and documentation skills.Knowledge of 21 CFR Part 820, ISO 13485.
This advertiser has chosen not to accept applicants from your region.
1
QA Specialist II
Cork, Munster
Gilead Sciences, Inc.
Posted 11 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**QA Specialist II position in QA Supplier Systems Group, Gilead Sciences Ireland UC Cork**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**The Position**
This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers used by GSIUC involving External audit Management, External Deviations, Quality agreement Management, Supplier introduction approval, Supplier notification assessment and Continuous Supplier monitoring.
This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
**Essential Duties and Job Functions:**
+ Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
+ Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers.
+ Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.
+ Approval of new supplier and material part numbers within Gilead's product lifecycle management system
+ Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider
+ Review of approval of Supplier appraisal reports
+ External Audit Management
+ Quality agreement Management
+ External Deviation approval
+ Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review
+ Ownership, assessment, and Approval of Supplier/Service provider Notifications including changes and quality issues.
+ External and Internal auditing
+ Support for regulatory and corporate audits.
+ Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
+ Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
+ Review and approval of GMP Deviation investigations and CAPAs if required.
+ Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
+ Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
+ Normally receives very little instruction on routine work, general instructions on new assignments.
**Knowledge, Experience and Skills:**
+ Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.
+ Experience with working with external suppliers is preferred and ability to act when quality issues are seen.
+ Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
+ Demonstrates working knowledge of quality assurance systems, methods, and procedures.
+ Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
+ Demonstrates audit and investigation skills, and report writing skills.
+ Good verbal, written, and interpersonal communication skills.
+ Proficiency in Microsoft Office applications.
**Typical Education & Experience:**
+ Relevant experience in a GMP environment related field and a BS or MS
**Behaviours:**
+ Positive attitude and enjoys working as part of a team
+ Resilient profile with the ability to deliver in a challenging environment
+ Ability to engage and manage multiple stakeholders to achieve the objective
+ Curious with learning agility
+ Operationally excellent
+ Organised with systematic approach to prioritisation
+ Process orientated to achieve the business objective
**Gilead Core Values:**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**QA Specialist II position in QA Supplier Systems Group, Gilead Sciences Ireland UC Cork**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**The Position**
This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers used by GSIUC involving External audit Management, External Deviations, Quality agreement Management, Supplier introduction approval, Supplier notification assessment and Continuous Supplier monitoring.
This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
**Essential Duties and Job Functions:**
+ Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
+ Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers.
+ Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.
+ Approval of new supplier and material part numbers within Gilead's product lifecycle management system
+ Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider
+ Review of approval of Supplier appraisal reports
+ External Audit Management
+ Quality agreement Management
+ External Deviation approval
+ Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review
+ Ownership, assessment, and Approval of Supplier/Service provider Notifications including changes and quality issues.
+ External and Internal auditing
+ Support for regulatory and corporate audits.
+ Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
+ Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
+ Review and approval of GMP Deviation investigations and CAPAs if required.
+ Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
+ Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
+ Normally receives very little instruction on routine work, general instructions on new assignments.
**Knowledge, Experience and Skills:**
+ Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.
+ Experience with working with external suppliers is preferred and ability to act when quality issues are seen.
+ Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
+ Demonstrates working knowledge of quality assurance systems, methods, and procedures.
+ Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
+ Demonstrates audit and investigation skills, and report writing skills.
+ Good verbal, written, and interpersonal communication skills.
+ Proficiency in Microsoft Office applications.
**Typical Education & Experience:**
+ Relevant experience in a GMP environment related field and a BS or MS
**Behaviours:**
+ Positive attitude and enjoys working as part of a team
+ Resilient profile with the ability to deliver in a challenging environment
+ Ability to engage and manage multiple stakeholders to achieve the objective
+ Curious with learning agility
+ Operationally excellent
+ Organised with systematic approach to prioritisation
+ Process orientated to achieve the business objective
**Gilead Core Values:**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
2
Quality Technician/Manufacturing Technician
Clonmel, Munster
Abbott
Posted 28 days ago
Job Viewed
Job Description
**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 115,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular Clonmel is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education. Our broad line of vascular devices Manufactured in Clonmel includes vessel closure, endovascular and coronary technologies-These devices are designed to treat heart attack, stroke, critical limb ischemia and other serious vascular conditions.
Abbott Vascular Clonmel is the largest Abbott Manufacturing facility in Ireland focusing on both manufacturing and research and development of next generation vascular products.
**We are currently on the look out for both Manufacturing Technicians and Quality Technicians.**
**As the Quality Technician, you will:**
+ Assist engineering in providing manufacturing support by reviewing and analysing data to determine manufacturing issues and trends. You may also train operators on processes and engineering changes, and perform operator certification on-the-job training and testing.
+ Resolve and prevent manufacturing issues by assisting engineering in determining root cause and implementing corrective and preventative action.
+ Review and disposition non-conforming material by utilising quality tools and by developing knowledge of manufacturing practices and procedures.
+ Develop and implements process improvements by assisting engineering in researching and validating changes in processes/equipment and test methods to improve yield and/or reduce cycle time per established procedures.
+ Support process development during new product introduction by defining traceability and inspection requirements, developing statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications.
+ Provide input to engineering, qualification, and validation studies and reports by collecting, compiling, measuring, organising and recording data, and by writing procedures. May keep lab notebook.
**EDUCATION & COMPETENCIES - QUALITY TECHNICIAN:**
+ (Education/ Experience) National Framework of Qualifications level 6 qualification in a relevant discipline and 4+ years of related work experience or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Applies extensive knowledge of advanced technical concepts and practices, and a complete understanding of product or systems fundamentals in a functional area, and working knowledge of other related disciplines. Utilises/interprets advanced numerical and statistical data and computer software programs to present documentation and analysis and resolve complex problems. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Performs complex technical assignments usually without established procedures. Assists in the design, development, evaluation or modification of all area-specific equipment, materials, systems, and/or product. May determine types of tests or develop preventative maintenance plans. Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement methods.
+ (Influence/Leadership) Mentor less senior employees in work group and offer counsel. Leads cross functional teams to resolve technical issues as required. Establishes effective channels of communication cross shift, site and functional groups.
+ (Planning/Organisation) Plans and organises non-routine tasks with approval. Initiates or maintains work schedule. Establishes priorities of work assignments.
+ (Decision Making/Impact) Solves a wide range of complex problems requiring advanced interpretation of generally defined procedures and practices. Selects methods and practices to obtain imaginative, thorough, and practical solutions to questions. Understands organisational structure and positions of key employees. Maintains general knowledge of products/services associated with the company and employees involved with specific product lines and services. Maintains confidentiality in handling sensitive information or documents.
+ (Communication) Regularly presents findings to cross-functional teams and begins to win support for ideas. Can adequately write procedures and product disposition documentation that may be presented to external auditing bodies.
+ (Supervision Received) Limited supervision. Receives no instruction on routine work and general instruction on new lines of work or special assignments.
**As the Manufacturing Technician, you will:**
+ Observe and comply with all safety rules and regulations. This includes Quality Systems Registrars (QSR) and International Organisation for Standardisation (ISO) Standards.
+ Identify and implement corrective actions for manufacturing related issues.
+ Performs equipment setup and corrective, preventive and calibration maintenance as necessary.
+ Install and validate equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
+ Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
+ Certify manufacturing associates in the production processes.
+ Evaluate and order necessary equipment, tools and fixtures.
**EDUCATION & COMPETENCIES - MANUFACTURING TECHNICIAN:**
+ (Experience/Education) National Framework of Qualifications (NFQ) level 6 qualification in a relevant discipline. Relevant work experience advantageous but not essential or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Applies limited knowledge of basic technical concepts and practices and a basic understanding of product or systems fundamentals. Utilises basic knowledge of numerical and/or statistical data and computer software programs to resolve routine problems. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Performs routine technical tasks working from detailed written or verbal instructions. Performs routine set-up, testing, repair, inspection, and/or maintenance of certain area-specific equipment, materials, systems, and/or product. Assignments require limited judgment in troubleshooting proven processes.
+ (Planning/Organisation) Completes daily work to meet established schedule with guidance from supervisor on prioritisation of tasks.
+ (Decision Making/Impact) Solves problems of limited scope and complexity requiring basic interpretation of well-defined procedures and practices. Maintains confidentiality in handling sensitive information or documents.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 115,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular Clonmel is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education. Our broad line of vascular devices Manufactured in Clonmel includes vessel closure, endovascular and coronary technologies-These devices are designed to treat heart attack, stroke, critical limb ischemia and other serious vascular conditions.
Abbott Vascular Clonmel is the largest Abbott Manufacturing facility in Ireland focusing on both manufacturing and research and development of next generation vascular products.
**We are currently on the look out for both Manufacturing Technicians and Quality Technicians.**
**As the Quality Technician, you will:**
+ Assist engineering in providing manufacturing support by reviewing and analysing data to determine manufacturing issues and trends. You may also train operators on processes and engineering changes, and perform operator certification on-the-job training and testing.
+ Resolve and prevent manufacturing issues by assisting engineering in determining root cause and implementing corrective and preventative action.
+ Review and disposition non-conforming material by utilising quality tools and by developing knowledge of manufacturing practices and procedures.
+ Develop and implements process improvements by assisting engineering in researching and validating changes in processes/equipment and test methods to improve yield and/or reduce cycle time per established procedures.
+ Support process development during new product introduction by defining traceability and inspection requirements, developing statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications.
+ Provide input to engineering, qualification, and validation studies and reports by collecting, compiling, measuring, organising and recording data, and by writing procedures. May keep lab notebook.
**EDUCATION & COMPETENCIES - QUALITY TECHNICIAN:**
+ (Education/ Experience) National Framework of Qualifications level 6 qualification in a relevant discipline and 4+ years of related work experience or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Applies extensive knowledge of advanced technical concepts and practices, and a complete understanding of product or systems fundamentals in a functional area, and working knowledge of other related disciplines. Utilises/interprets advanced numerical and statistical data and computer software programs to present documentation and analysis and resolve complex problems. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Performs complex technical assignments usually without established procedures. Assists in the design, development, evaluation or modification of all area-specific equipment, materials, systems, and/or product. May determine types of tests or develop preventative maintenance plans. Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement methods.
+ (Influence/Leadership) Mentor less senior employees in work group and offer counsel. Leads cross functional teams to resolve technical issues as required. Establishes effective channels of communication cross shift, site and functional groups.
+ (Planning/Organisation) Plans and organises non-routine tasks with approval. Initiates or maintains work schedule. Establishes priorities of work assignments.
+ (Decision Making/Impact) Solves a wide range of complex problems requiring advanced interpretation of generally defined procedures and practices. Selects methods and practices to obtain imaginative, thorough, and practical solutions to questions. Understands organisational structure and positions of key employees. Maintains general knowledge of products/services associated with the company and employees involved with specific product lines and services. Maintains confidentiality in handling sensitive information or documents.
+ (Communication) Regularly presents findings to cross-functional teams and begins to win support for ideas. Can adequately write procedures and product disposition documentation that may be presented to external auditing bodies.
+ (Supervision Received) Limited supervision. Receives no instruction on routine work and general instruction on new lines of work or special assignments.
**As the Manufacturing Technician, you will:**
+ Observe and comply with all safety rules and regulations. This includes Quality Systems Registrars (QSR) and International Organisation for Standardisation (ISO) Standards.
+ Identify and implement corrective actions for manufacturing related issues.
+ Performs equipment setup and corrective, preventive and calibration maintenance as necessary.
+ Install and validate equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
+ Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
+ Certify manufacturing associates in the production processes.
+ Evaluate and order necessary equipment, tools and fixtures.
**EDUCATION & COMPETENCIES - MANUFACTURING TECHNICIAN:**
+ (Experience/Education) National Framework of Qualifications (NFQ) level 6 qualification in a relevant discipline. Relevant work experience advantageous but not essential or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Applies limited knowledge of basic technical concepts and practices and a basic understanding of product or systems fundamentals. Utilises basic knowledge of numerical and/or statistical data and computer software programs to resolve routine problems. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Performs routine technical tasks working from detailed written or verbal instructions. Performs routine set-up, testing, repair, inspection, and/or maintenance of certain area-specific equipment, materials, systems, and/or product. Assignments require limited judgment in troubleshooting proven processes.
+ (Planning/Organisation) Completes daily work to meet established schedule with guidance from supervisor on prioritisation of tasks.
+ (Decision Making/Impact) Solves problems of limited scope and complexity requiring basic interpretation of well-defined procedures and practices. Maintains confidentiality in handling sensitive information or documents.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
3
QA Warehouse Specialist
Blanchardstown, Leinster
PCI Pharma Services
Posted 17 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
4
QA Warehouse Specialist
PCI Pharma Services
Posted 17 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
5
Manager, Quality Control
Sligo, Connacht
AbbVie
Posted 5 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Manufacturing qa Jobs in Ireland !
6
Manager Quality Control
Limerick, Munster
Regeneron Ireland DAC
Posted 1 day ago
Job Viewed
Job Description
Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
7
Quality Control Analyst
Waterford, Munster
Cpl Resources
Posted 1 day ago
Job Viewed
Job Description
We are currently seeking a QC Analyst with previous industry experience to join our client's site in Waterford on an initial 12 months contract. Key responsibilities: Provide analytical chemistry services and support to Site. Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners. Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements. Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates. Trend such results, record on COAs where required and complete OOSs investigations on a timely basis. Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means. Ensure all quality documentation and records are complete and current. Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements. Ensure relevant procedures are correctly defined and followed. Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required. Audit and review chemistry test results on a daily basis and ensure compliance with cGLP. Checking/auditing laboratory notebooks and analytical reports Ensure compliance to cGMP at all times. Qualifications: Degree in Science (Chemistry or Biochemistry preferred). Postgraduate studies as appropriate to augment primary degree. 2-3 years experience working in a manufacturing environment ideally part of which would be in the pharmaceutical sector. Experience with some of the following tests: HPLC/UPLC, SDS-PAGE, Karl Fischer, HIAC, micro pipetting and ELISA. Skills: HPLC GMP Karl Fisher SDS-PAGE ELISA
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QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 28 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
9