58 Senior Qa Specialist jobs in Ireland
QA Specialist II
Cork, Munster
Gilead Sciences, Inc.
Posted 20 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.
0
Senior QA Specialist
Tipperary, Munster
Tandem Project Management Limited
Posted 2 days ago
Job Viewed
Job Description
Summary: A Senior QA Specialist is required for a pharmaceutical company in South Tipperary. The successful candidate will ensure that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. Onsite attendance is required during the training period. After training, the position offers one day of remote working per week. Responsibilities: Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements. Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making. Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates. Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance. Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies. Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks. Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement. Qualifications & Experience: Degree in Science, Quality, or a related technical field. 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments. Strong written and verbal communication skills, capable of clearly articulating complex quality issues. Logical thinker with the ability to remain proactive and composed under pressure. Proven ability to work effectively both independently and collaboratively within a team. Exceptional attention to detail and precision in preparing and reviewing GMP documentation. Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.
This advertiser has chosen not to accept applicants from your region.
1
QA Specialist | Packaging
Cork, Munster
Catalyx
Posted 3 days ago
Job Viewed
Job Description
Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers. Who We Are: Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes-globally-with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit . The Role: Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations. Responsibilities: Deliver Quality Assurance support to the Packaging Department. Evaluate and approve GxP documentation. Conduct Batch Record Review and Batch Disposition processes. Update Quality Assurance Standard Operating Procedures (SOPs) as necessary. Scan and archive documents as needed. Inspect finished products. Perform investigations into deviations and conduct Root Cause Analysis. Generate reports for customer complaints. Conduct line clearance for packaging areas. Suggest process enhancements and recommend changes. Assist with internal and regulatory audits/inspections as required. Support the training and mentoring of new employees. Provide additional support and assistance on tasks and projects as directed by management. Collaborate with cross-functional teams. Achieve agreed-upon KPIs and metrics. Perform other duties as necessary. Skills and Experience: A relevant third-level qualification in a QA discipline. A minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector. Experience with Batch Record Review in Pharma/Med Devices is essential. Demonstrable understanding of Document Control principles, Quality Systems, and GMP requirements. Comprehensive knowledge of document control processes and the relationship between document change processes and products. Familiarity with the current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines. Proficiency with Electronic Document Management Systems (EDMS). Stay informed about compliance requirements in your work area. Exhibit strong problem-solving skills with attention to detail. Proficiency in Microsoft Office applications and experience with Oracle. Excellent written and verbal communication skills, coupled with strong interpersonal skills. A proactive attitude toward customer service and performance. Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone. At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
2
QA Specialist/Qualified Person
Cork, Munster
GE HealthCare
Posted 4 days ago
Job Viewed
Job Description
**Job Description Summary**
Join GE HealthCare's Medical Diagnostics team as a QA Specialist/Qualified Person, where you'll play a key role in ensuring our QA activities meet global regulatory standards. Collaborating with dynamic internal teams-like Manufacturing, Supply Chain, and Regulatory Affairs-and engaging with external partners including distributors, suppliers, and regulators, you'll help drive excellence and compliance across our operations in a fast-paced, impactful environment.
**Job Description**
**Responsibilities:**
+ Provide quality assurance oversight on all X Ray & MRI products manufactured by GEHC, Cork covering all stages of product lifecycle i.e. preparation, manufacture, testing, packaging, labelling, storage, transportation, distribution, complaint handling, documentation and record keeping.
+ Work with other internal support functions to ensure all processes are designed, implemented and maintained to meet relevant requirements.
+ Manage the batch record review and final QP disposition of manufactured batches as per Annex 16 release requirements.
+ Review complaints as required related to GEHC Cork and take appropriate action to prevent recurrence.
+ Involvement in regular audits to assess the effectiveness of quality systems, identify any non-conformances and recommend corrective actions.
+ Maintain accurate records of all quality assurance activities.
+ Coordinate the conduct of investigations into quality issues identified through internal or external sources.
+ Collaborate with distributors and customers on quality matters.
+ Actively participate in cross functional investigations/projects as required.
+ Ensure timely communication and reporting to senior management regarding significant product quality issues.
**Qualifications and Requirements**
+ Bachelor's degree(2.1 or above) in a relevant discipline such as: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or equivalent
+ Strong experience in a Quality Assurance role within a Life Sciences industry.
+ Strong knowledge of cGMP requirements, EU Directives & Regulations 2001/83/EC, Eurdralex Volume 4, specifically focusing on Annex 13 & Annex 16 requirements .
**Desired Skills**
+ Advanced computer skills, particularly Microsoft Office Suite, Excel. Familiarity with validated quality systems e.g. Trackwise Digital, Veeva Vault and Compliance Wire a bonus.
+ Proficiency in written and spoken English language essential.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-BG1
#LI-onsite
**Additional Information**
**Relocation Assistance Provided:** No
Join GE HealthCare's Medical Diagnostics team as a QA Specialist/Qualified Person, where you'll play a key role in ensuring our QA activities meet global regulatory standards. Collaborating with dynamic internal teams-like Manufacturing, Supply Chain, and Regulatory Affairs-and engaging with external partners including distributors, suppliers, and regulators, you'll help drive excellence and compliance across our operations in a fast-paced, impactful environment.
**Job Description**
**Responsibilities:**
+ Provide quality assurance oversight on all X Ray & MRI products manufactured by GEHC, Cork covering all stages of product lifecycle i.e. preparation, manufacture, testing, packaging, labelling, storage, transportation, distribution, complaint handling, documentation and record keeping.
+ Work with other internal support functions to ensure all processes are designed, implemented and maintained to meet relevant requirements.
+ Manage the batch record review and final QP disposition of manufactured batches as per Annex 16 release requirements.
+ Review complaints as required related to GEHC Cork and take appropriate action to prevent recurrence.
+ Involvement in regular audits to assess the effectiveness of quality systems, identify any non-conformances and recommend corrective actions.
+ Maintain accurate records of all quality assurance activities.
+ Coordinate the conduct of investigations into quality issues identified through internal or external sources.
+ Collaborate with distributors and customers on quality matters.
+ Actively participate in cross functional investigations/projects as required.
+ Ensure timely communication and reporting to senior management regarding significant product quality issues.
**Qualifications and Requirements**
+ Bachelor's degree(2.1 or above) in a relevant discipline such as: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or equivalent
+ Strong experience in a Quality Assurance role within a Life Sciences industry.
+ Strong knowledge of cGMP requirements, EU Directives & Regulations 2001/83/EC, Eurdralex Volume 4, specifically focusing on Annex 13 & Annex 16 requirements .
**Desired Skills**
+ Advanced computer skills, particularly Microsoft Office Suite, Excel. Familiarity with validated quality systems e.g. Trackwise Digital, Veeva Vault and Compliance Wire a bonus.
+ Proficiency in written and spoken English language essential.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-BG1
#LI-onsite
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
3
Senior QA Specialist (hybrid)
Tipperary, Munster
Life Science Recruitment Ltd
Posted 3 days ago
Job Viewed
Job Description
Senior QA Specialist (hybrid) RK Months Tipperary Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence. Key Responsibilities: Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements. Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making. Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates. Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance. Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies. Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks. Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement. Education and Experience: Degree in Science, Quality, or a related Technical field. 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments. Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
This advertiser has chosen not to accept applicants from your region.
4
QA Warehouse Specialist
Blanchardstown, Leinster
PCI Pharma Services
Posted 26 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
QA Warehouse Specialist
PCI Pharma Services
Posted 26 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.
Be The First To Know
About the latest Senior qa specialist Jobs in Ireland !
6
Manager, Quality Control
Sligo, Connacht
AbbVie
Posted 14 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.
7
Quality Control Technician
Donegal, Ulster
Vertiv
Posted 1 day ago
Job Viewed
Job Description
POSITION SUMMARY The Quality Control Technician is responsible for monitoring and testing products throughout the manufacturing process to ensure they meet quality standards and specifications. This position plays a crucial role in maintaining product quality and consistency across production and fabrication lines. RESPONSIBILITIES Perform quality inspections and testing of products during various stages of production Document inspection results and maintain detailed quality records Identify and report quality defects and non-conformances Conduct incoming inspection Calibrate and maintain testing equipment Support continuous improvement initiatives Collaborate with production teams to resolve quality issues Other responsibilities may be assigned from time to time as needed QUALIFICATIONS Minimum Job Qualifications: 2 years of experience in the position English 90% Preferred Qualifications: Ability to read and interpret engineering drawings Experience with measurement tools and testing equipment Knowledge of quality control methodologies Experience with Switchgear, UPS, CRAC units, STS, or busbar systems is a plus Knowledge of ISO 9001 requirements Positive mindset Autonomy and proactivity Ability to complete tasks in timely manner PHYSICAL & ENVIRONMENTAL DEMANDS Frequent Standing and moving within manufacturing environment Working in a manufacturing environment around machinery and equipment# Protective Equipment Required (safety shoes, eyewear, earplugs, gloves, etc. where required) TIME TRAVEL REQUIRED No travel required #vertivireland To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
8
Manager Quality Control
Limerick, Munster
Regeneron Ireland DAC
Posted 3 days 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.
9