57 Quality Management jobs in Ireland

Quality Management System Lead

Dublin, Leinster Elusav Recruitment

Posted 13 days ago

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Elusav Recruitment have an excellent opportunity for aQuality Management System Lead for aleading engineering services company in Dublin. The Quality Management System Lead is responsible for continuously refining and optimizing operational procedures and controls within our Quality Management Systems. This includes, but is not limited to, systems related to Quality, Environmental, and Health & Safety, ensuring effective integration and alignment with broader Group functions and management systems. Responsibilities of the Role: Quality Management System (QMS) "Architecture" Oversight: Design, implement, and maintain a robust and compliant Quality Management System (QMS) tailored to industry standards such ISO 9001, ISO 45001, ISO 14001 and 50001 to fit the business needs. Ensure all quality documentation is controlled and audit-ready, conduct regular QMS reviews. Annual Management Review Support: Assist in preparing and participating in the annual management review with all stakeholders by compiling quality data, audit results, and improvement actions; support presentation development; document outcomes and follow up on agreed actions. Cross-Functional Regulatory Alignment: Collaborate with Group functions to ensure seamless integration and alignment of country-specific quality requirements, including Building Control regulations in Ireland, the Building Safety Act in the UK, and other EU national quality standards, ensuring compliance and consistency across all regions. Quality Cycle: Assist the implementation, monitoring, and continuous improvement of the Quality Cycle by integrating its principles into daily operations, aligning it with the QMS, training staff on its application, tracking performance against benchmarks, and using feedback loops to refine processes and ensure quality excellence. Digital Tools & Technology Utilisation: Leverage digital tools and platforms to enhance quality management processes, including QMS software, statistical analysis tools, cloud-based collaboration tools; implement automation where feasible to streamline data collection, reporting, and compliance tracking. Data Analysis & Reporting: Participate the development and monitor key quality performance indicators (KPIs) such as defect/snag rates, "Right First Time", and "Cost of poor quality", use statistical tools (e.g., SPC, Pareto analysis, control charts) to analyse trends, prepare detailed quality reports for senior leadership, and maintain visual dashboards in Power Bi to communicate performance across the organisation. Internal & External Audits: Plan, schedule, and execute comprehensive internal audits, coordinate third-party and regulatory audits, manage audit findings and non-conformities, and ensure timely implementation and verification of corrective actions to maintain compliance and certification status. Supply Chain Quality Management: Develop and enforce supplier quality requirements, conduct supplier audits, collaborate with procurement and engineering to qualify and monitor suppliers, manage supplier non-conformances through structured corrective action processes, and drive continuous improvement in supplier performance. Nonconformance Management: Identify, document, and manage product and process nonconformances across all operational areas; lead investigations to determine root causes; coordinate containment actions to minimize impact; initiate and track corrective actions; maintain a nonconformance log; analyse trends to identify recurring issues; and report findings to leadership with recommendations for systemic improvements. Root Cause Analysis & CAPA Management: Lead structured root cause investigations using tools such as 5 Whys, manage the full lifecycle of corrective and preventive actions (CAPA), maintain a centralised CAPA tracking system, and ensure effectiveness verification and closure of actions to prevent recurrence of quality issues. Lessons Learned Management: Maintain a structured process for capturing, documenting, and sharing lessons learned from quality incidents, audits, project feedback and improvement initiatives across the department and wider organisation; facilitate regular reviews to ensure lessons are integrated into SOPs, training, and preventive strategies; and promote a culture of knowledge sharing and continuous learning. Continuous Improvement & Innovation: Lead Lean, Six Sigma, and other initiatives to improve process efficiency and reduce waste, facilitate workshops such as value stream mapping and process mapping, benchmark industry best practices, integrate innovative quality tools and technologies and promote employee engagement in continuous improvement activities. Training & Development: Develop and deliver comprehensive quality training programs for Quality staff and cross-functional teams, ensure all employees are trained and competent in relevant SOPs and standards, maintain training records and matrices, and evaluate training effectiveness through audits and performance assessments. Knowledge Sharing: Contribute quality-related insights, best practices, and lessons learned to the Group Knowledge Hub to support organisational learning, cross-functional collaboration, and continuous improvement across regions. Quality Risk Management: Conduct comprehensive QEHS risk assessments for new projects, processes, and supply chain using applicable tools and risk matrices, develop and implement mitigation plans and control strategies, participate in design and process reviews to embed quality early in development, and monitor emerging risks and incidents to ensure proactive management. Customer Quality Interface: Act as the primary liaison for customer quality concerns, manage complaint investigations and formal responses, track and analyse customer satisfaction metrics, participate in customer audits and quality reviews, and implement initiatives to improve customer experience and trust in product quality. Requirements: Min 2 years in a senior Q/ EHS role in a large construction or engineering business and / or 8-10 + years' experience in Data Centres or petrochemical and / or within a multinational manufacturing or Pharma/Advanced Tech environment. Minimum Diploma or Degree in Engineering, equivalent to BSc, in Construction / engineering background / Quality Management systems and auditing / Occupational EH&S. Experience in Microsoft packages, knowledge of Digital Platforms such as BIM 360, ACC, Procore, Aconex and other Common Data Environment software. ISO 9001:2015 Lead Auditor. Desirable to be a chartered member of CQI, IEI, CIOB or other construction related institute or in the process of achieving that level. Six Sigma Green or higher Belt. PMP (Project Management Professional) certificate by PMI. Contact: If you would like to learn more about the vacancy, apply now, or contact Aaron Gallagher on or . Skills: Six Sigma EHS BIM 360
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Sr Dir GD Quality Management (GVP)

Dublin, Leinster Regeneron Ireland DAC

Posted 9 days ago

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Join us as we shape the future of healthcare through innovation, integrity, and excellence. We are seeking an experienced leader to take on the role of Senior Director, Global Development Quality Management (GVP). This pivotal position offers the opportunity to drive strategy, lead quality initiatives, and collaborate globally to ensure compliance and excellence in drug development and pharmacovigilance practices. As a member of the GDQGO Leadership Team, you will play an integral role in advancing our mission while fostering innovation, quality, and collaboration across global functions. A Typical Day: In this role, you will: Lead the GDQM (GVP) sub-function, providing strategic direction and operational oversight. Ensure proactive, risk-based approaches to quality and compliance within Regeneron's Quality Management System (QMS). Collaborate with cross-functional teams to support Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Medical and Regulatory Affairs. Oversee timely issue escalation, risk management activities, and inspection readiness. Manage team resources, including hiring strategies, onboarding, and performance reviews. Represent the GDQGO sub-function during regulatory inspections and cross-functional forums. Drive process improvement initiatives and champion innovation to enhance quality objectives. This Role May Be For You If you: Are a strategic thinker with expert knowledge in GVP Quality and local affiliate QMS oversight. Have a proven ability to lead cross-functional teams and build strong stakeholder relationships. Thrive in a collaborative environment and are skilled at balancing strategic vision with operational execution. Are adept at identifying risks and embedding proactive quality management approaches. Possess exceptional communication skills and can effectively deliver key messages to executive leadership and cross-functional teams. Excel at managing resources, fostering team growth, and driving large-scale quality initiatives. To Be Considered: We are looking for candidates with: Extensive experience in quality management, particularly in GVP, GCP, and regulatory affairs. A strong track record of leadership in global functions and cross-functional collaboration. Expertise in risk-based quality management and inspection readiness strategies. A passion for driving innovation and process improvement in quality systems. Preferred qualifications include familiarity with Regeneron's global PV system and experience representing quality functions during regulatory inspections. Why Join Us? At Regeneron, we believe in the power of collaboration, innovation, and a commitment to excellence. As the Head of Global Development Quality Management (GVP), you will have the opportunity to make a meaningful impact on our mission to bring life-changing medicines to patients worldwide. Join us and be part of a team that exemplifies quality, integrity, and leadership in every interaction. 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.
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Group Quality Management System Lead, Dublin, Ireland

Dublin, Leinster Mercury Engineering Ltd

Posted 13 days ago

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Mercury is the European leader in construction solutions. We build and manage complex engineering & construction projects for the world's leading corporations. Our solutions help deliver technologies and life changing advancements that connect people, communities, and businesses, giving them the power to achieve incredible things. Our people have the courage to be innovative. Their determination and sharp focus enable us to deliver with certainty, time and time again. We deliver our clients' visions through leading edge construction solutions across multiple sectors, including Enterprise Data Centres, Advanced Technology & Life Sciences, Hyperscale Data Centres, Fire Protection. At Mercury, it is our duty to encourage and back our people to realise their vision of themselves. We place them at the heart of what we do, providing challenging opportunities to develop within a great team in a supportive environment that allows them to reach their full potential. Scope of the Role: The Quality Management System Lead is responsible for continuously refining and optimizing operational procedures and controls within our Quality Management Systems. This includes, but is not limited to, systems related to Quality, Environmental, and Health & Safety, ensuring effective integration and alignment with broader Group functions and management systems. The role requires a strong understanding of how large, multi-disciplinary construction and engineering organisations operate-particularly the interface between field operations and support functions. Experience with a variety of client management systems and the ability to learn from other sectors will be key to driving the transformation and performance improvements we seek. This position plays a critical role in fostering a culture of learning, collaboration, and knowledge sharing. The successful candidate will be a strong team leader who motivates and empowers individuals and teams to embrace change and continuous improvement. Regular travel to operational sites across the division and in multiple geographies is required to support implementation, engagement, compliance monitoring, auditing and alignment with local and regional quality requirements. Key Responsibilities of the Role: Quality Management System (QMS) "Architecture" Oversight: Design, implement, and maintain a robust and compliant Quality Management System (QMS) tailored to industry standards such ISO 9001, ISO 45001, ISO 14001 and 50001 to fit the business needs. Ensure all quality documentation is controlled and audit-ready, conduct regular QMS reviews. Annual Management Review Support: Assist in preparing and participating in the annual management review with all stakeholders by compiling quality data, audit results, and improvement actions; support presentation development; document outcomes and follow up on agreed actions. Cross-Functional Regulatory Alignment: Collaborate with Group functions to ensure seamless integration and alignment of country-specific quality requirements, including Building Control regulations in Ireland, the Building Safety Act in the UK, and other EU national quality standards, ensuring compliance and consistency across all regions. Mercury Quality Cycle: Assist the implementation, monitoring, and continuous improvement of the Mercury Quality Cycle by integrating its principles into daily operations, aligning it with the QMS, training staff on its application, tracking performance against Mercury benchmarks, and using feedback loops to refine processes and ensure quality excellence. Digital Tools & Technology Utilisation: Leverage digital tools and platforms to enhance quality management processes, including QMS software, statistical analysis tools, cloud-based collaboration tools; implement automation where feasible to streamline data collection, reporting, and compliance tracking. Data Analysis & Reporting: Participate the development and monitor key quality performance indicators (KPIs) such as defect/snag rates, "Right First Time", and "Cost of poor quality", use statistical tools (e.g., SPC, Pareto analysis, control charts) to analyse trends, prepare detailed quality reports for senior leadership, and maintain visual dashboards in Power Bi to communicate performance across the organisation. Internal & External Audits: Plan, schedule, and execute comprehensive internal audits, coordinate third-party and regulatory audits, manage audit findings and non-conformities, and ensure timely implementation and verification of corrective actions to maintain compliance and certification status. Supply Chain Quality Management: Develop and enforce supplier quality requirements, conduct supplier audits, collaborate with procurement and engineering to qualify and monitor suppliers, manage supplier non-conformances through structured corrective action processes, and drive continuous improvement in supplier performance. Nonconformance Management: Identify, document, and manage product and process nonconformances across all operational areas; lead investigations to determine root causes; coordinate containment actions to minimize impact; initiate and track corrective actions; maintain a nonconformance log; analyse trends to identify recurring issues; and report findings to leadership with recommendations for systemic improvements. Root Cause Analysis & CAPA Management: Lead structured root cause investigations using tools such as 5 Whys, manage the full lifecycle of corrective and preventive actions (CAPA), maintain a centralised CAPA tracking system, and ensure effectiveness verification and closure of actions to prevent recurrence of quality issues. Lessons Learned Management: Maintain a structured process for capturing, documenting, and sharing lessons learned from quality incidents, audits, project feedback and improvement initiatives across the department and wider organisation; facilitate regular reviews to ensure lessons are integrated into SOPs, training, and preventive strategies; and promote a culture of knowledge sharing and continuous learning. Continuous Improvement & Innovation: Lead Lean, Six Sigma, and other initiatives to improve process efficiency and reduce waste, facilitate workshops such as value stream mapping and process mapping, benchmark industry best practices, integrate innovative quality tools and technologies and promote employee engagement in continuous improvement activities. Training & Development: Develop and deliver comprehensive quality training programs for Quality staff and cross-functional teams, ensure all employees are trained and competent in relevant SOPs and standards, maintain training records and matrices, and evaluate training effectiveness through audits and performance assessments. Knowledge Sharing: Contribute quality-related insights, best practices, and lessons learned to the Group Knowledge Hub to support organisational learning, cross-functional collaboration, and continuous improvement across regions. Quality Risk Management: Conduct comprehensive QEHS risk assessments for new projects, processes, and supply chain using applicable tools and risk matrices, develop and implement mitigation plans and control strategies, participate in design and process reviews to embed quality early in development, and monitor emerging risks and incidents to ensure proactive management. Customer Quality Interface: Act as the primary liaison for customer quality concerns, manage complaint investigations and formal responses, track and analyse customer satisfaction metrics, participate in customer audits and quality reviews, and implement initiatives to improve customer experience and trust in product quality. Essential Criteria for the Role: Min 2 years in a senior Q/ EHS role in a large construction or engineering business and / or 8-10 + years' experience in Data Centres or petrochemical and / or within a multinational manufacturing or Pharma/Advanced Tech environment. Minimum Diploma or Degree in Engineering, equivalent to BSc, in Construction / engineering background / Quality Management systems and auditing / Occupational EH&S. Experience in Microsoft packages, knowledge of Digital Platforms such as BIM 360, ACC, Procore, Aconex and other Common Data Environment software. ISO 9001:2015 Lead Auditor. :Key Competencies High levels of Professionalism and Ethics in all undertakings, interactions and behaviours. Have a real passion for continuous improvement, applied learning, early adaptor and have a curious and innovative mindset. Strong teamwork, listening and negotiating skills. Excellent stakeholder management and collaboration skills. Negotiation, presenting and Influencing skills, Train the Trainer skillset. High ability to develop, read and interpret QMS documents such Plans, Procedures (SOPs), Inspection and Test Plans and others. Desirable Criteria Desirable to be a chartered member of CQI, IEI, CIOB or other construction related institute or in the process of achieving that level. Six Sigma Green or higher Belt. PMP (Project Management Professional) certificate by PMI. Mercury is an equal opportunities employer .
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Quality Control Analyst

Sligo, Connacht AbbVie

Posted today

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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 currently recruiting a QC Analyst for our high-performing team in Manorhamilton Rd, Sligo. This is a 12 month fixed-term contract. This is also a rotating shift position.
A snapshot of your key responsibilities as a QC Analyst would be:
+ Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
+ Understand Regulations and business processes required to maintain Laboratory Data Integrity.
+ Be responsible for housekeeping duties in the lab.
+ Be responsible for the timely completion of chemical testing of raw material.
+ Ensure that all test equipment is used and maintained correctly.
+ Be responsible for raising change requests and data verification as assigned.
+ Ensure all in-process sampling and testing are completed in a timely manner.
+ Maintain up-to-date, complete, and precise records of all tests performed.
+ Adhere to cGMP and GLP requirements.
+ Assist in the resolution of quality problems as required.
+ Develop and change in-house laboratory procedures as appropriate.
+ Aid in training of new analyst.
+ Support the transfer of new products.
+ Adhere to and support all EHS & E standards, procedures and policies.
Qualifications
+ 3rd level qualification in a relevant Science discipline required.
+ A minimum of 6 months of experience in HPLC or GC.
+ Experience operating to cGMP standards utilizing laboratory equipment.
+ Previous experience in a pharmaceutical manufacturing environment is desirable but not essential.
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:
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Manager, Quality Control

Sligo, Connacht AbbVie

Posted 2 days ago

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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:
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Manager Quality Control

Limerick, Munster Regeneron Ireland DAC

Posted 13 days ago

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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.
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Quality Control Chemistry Manager

Dublin, Leinster Grifols Shared Services North America, Inc

Posted 2 days ago

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We're excited to invite you to lead our Quality Control (QC) Chemistry Laboratory team in our purification and aseptic filling facility at Grifols Worldwide Operations (GWWO). As **QC Chemistry Manager** , you will play a key role in ensuring high-quality laboratory testing of clean utility, raw material, in-process and final container materials, maintaining full compliance with current Good Manufacturing Practices (cGMP) and safety standards.
**Key Responsibilities:**
- Management of the QC Chemistry team to carry out required chemistry, immunochemistry and protein testing as required
- Ensure QC testing of clean utility, raw material, in-process and final container testing is performed as per the production plan
- Manage integrity of Laboratory Data
- Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
- Ensure all equipment is validated, maintained, calibrated, and requalified in line with site procedures and regulatory/compendial requirements
- Creation, review and update of test methods and SOPs to ensure all aspects of compliance are adhered to
- Drive and oversee process/product/OOS/deviation investigations
- Implementation of Corrective and Preventative Actions
- Maintain, monitor and report QC Chemistry metrics and KPIs
- Ensure training and development of QC Chemistry team members in conjunction with team development and goals via the performance management process
- Represent QC Chemistry in any regulatory, corporate or internal audits
- Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
- Support site quality activities, including but not limited to: Annual Product Quality Reviews (APQRs), recall activities, change control etc.
- Responsible for any projects impacting QC Chemistry such as Method Transfers, Process Improvement or Harmonisation Projects
- Keep Abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
- Manage the safety and performance of QC Chemistry in line with safety regulations and site procedures
- Perform additional duties as assigned
- Act as a delegate for activities performed by the QC Senior Manager for QC Chemistry activities
**Knowledge & Skills:**
- Full understanding of relevant cGMP, quality and compliance regulations
- Experience with chromatography instrumentation and methods
- Experience with protein chemistry instrumentation and methods
- Method Transfer and qualification experience
- Understanding of pharmacopoeial requirements and methods
- Excellent communication skills at organisation, team and individual levels
- Demonstrated problem solving skills
- Strong decision making skills
- Strong presentation skills
- Ability to manage multiple projects to plan/budget
- Experience in developing analytical methods is desirable
- Experience with Statistical Process Control (SPC) is desirable
- Experience with Lab Management Systems & SAP is desirable
**Qualifications:**
- BSc or equivalent in chemistry, biochemistry, pharmaceutical science or related field
- Minimum 3 years supervisory/management experience
- 8 years progressive experience as an individual contributor in a fast paced GMP Laboratory environment
- M.Sc. qualification is desirable but not essential
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates up to 7%
+ Private Medical Insurance for the employee
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Golf, Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you.
#LI-FD1
**Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols
**Req ID:**
**Type:** Regular Full-Time
**Job Category:**
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Junior Quality Control Engineer

Limerick, Munster Commissioning Agents (CAI)

Posted 3 days ago

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Junior to Mid-Level Quality Control/Validation Engineer IRELAND, IRELAND / NORTH EUROPE / FULL TIME About CAI: CAI is a 100% employee-owned company established in 1996, growing year over year to nearly 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in FDA regulated and other mission-critical industries. Are You Ready?: Our approach is simple: we put the clients interests first, we do not stop until it is right, and we will do whatever it takes to get there. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: - We act with integrity - We serve each other - We serve society - We work for our future With employee ownership, one persons success is everyones success. We work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially. CAI agents will be exposed to cutting-edge technologies in the advanced medicine space, working alongside recognized subject matter experts. As part of our culture, we invest in YOUR future through hands-on certifications and professional training. Position Overview: We are looking for a Junior to Mid-Level Validation Engineer to join our growing operations in Ireland. This role is designed for individuals with at least 2 years of relevant experience in Validation Engineering or Quality Control. As a Junior to Mid-Level Engineer, you will work alongside senior team members, assisting in maintaining quality standards and ensuring compliance throughout all equipment qualification activities. Key Responsibilities: - Support and assist with Quality Control compliance for equipment qualification activities, ensuring adherence to safety and regulatory standards. - Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail. - Follow established procedures and protocols for new equipment qualification to help embed quality practices within workflows. - Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications. - Support the planning and organization of commissioning materials and consumables, ensuring they meet required quality standards. - Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards. - Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards. - Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes. - Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking. - Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld. - Provide support for quality assurance tasks throughout the equipment qualification process, ensuring consistent quality standards are maintained. Position Requirements: - BS or MS in a relevant science or engineering field, or equivalent experience. - 2+ years of industry-related experience in a similar role. - Strong oral and written communication skills, with a focus on clear documentation and reporting. - Strong problem-solving skills with a focus on Quality Control. - Customer-service oriented and able to collaborate well with internal teams and external vendors. - Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience. - Willing and able to travel domestically and internationally, if required. Skills: Quality Control QC Technican Equipment Validation Life Science Bio-Pharma Pharmaceutical Manufacturing Benefits: Pension Fund Medical Aid / Health Care Dental Care Income Protection Group Life Assurance
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2026 Graduate Quality Control Analyst

Ringaskiddy, Munster J&J Family of Companies

Posted 2 days ago

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Professional
**All Job Posting Locations:**
Ringaskiddy, Cork, Ireland
**Job Description:**
**Position:** Graduate Quality Control Analyst
**Start Date:** September 2026
**Location:** Cork, Ireland
**Johnson & Johnson Innovative Medicine** established its operation in Ringaskiddy in 2005 on a 100-acre site with an investment of 500 million. For more than 25 years we have been a global leader in the field of biomedicines, particularly in groundbreaking monoclonal antibody technology, an approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is fully operational and currently expanding its operations to continue focusing on producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments.
**ABOUT THE JOHNSON & JOHNSON GRADUATE PROGRAMME**
The Graduate Programme is a collaborative programme across the Johnson & Johnson Campus Ireland Sites. It is aimed at high potential individuals who, when given the right tools, are empowered to proactively take responsibility, effect change and make a positive contribution to their teams and the business.
**THE SUCCESSFUL CANDIDATE WILL HAVE THE OPPORTUNITY TO:**
+ Develop relevant technical skills within their area of expertise.
+ Experience cross functional exposure both on site and within Campus Ireland.
+ Participate in regular one to ones and feedback to support your on-going development.
+ Engage in personal development and effectiveness training.
+ Develop influencing & communication skills.
+ Gain Project Management experience.
+ Learn new and innovative technologies.
+ Gain exposure to Senior Management Team.
+ Participate in continuous professional development program with a recognised qualification.
**JOB PURPOSE:**
We have an exciting opportunity for a QC Analyst on the Ireland Graduate Program. This individual will be responsible for carrying out tasks and projects related to the analysis of biotechnology products as required by Good Manufacturing practice (GMP). The individual will participate in the delivery of lab testing efforts by using both existing and new procedures or processes to independently interpret data and identify and correct issues. Proposes ideas and next steps to supervisors and/or managers. Receives intermittent, moderately detailed instructions from Quality leaders at various levels, in addition to other partners.
**WHAT YOU'RE GREAT AT:**
+ Analytical testing knowledge including an understanding of Biopharmaceutical manufacturing and batch release processes.
+ Knowledge of equipment qualification, analytical method transfers, root cause problem solving and continuous improvement desirable.
+ A strong teammate who is very customer focused, possesses leadership and testing skills and both stakeholder and project management experience.
+ Strong collaboration & interpersonal skills, both written and oral.
**AS A QC ANALYST YOUR TYPICAL DAY MAY INCLUDE:**
+ Supporting the QC Team Leader during day to day operations of area.
+ Testing for laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
+ Performing IP/ Microbiology/ Bioassay/ Separations analysis.
+ Identifying and implementing laboratory process improvements leading to improved efficiency &/or compliance within area.
+ Authors and investigates internal investigations, participates in regulatory inspections & external technical discussions etc.
+ Keeping up to date with analytical technology and regulatory / compliance trends.
+ Participates in technical groups to implement laboratory activities while following local and global regulatory requirements as well as J&J standards.
+ Supports the roll-out of laboratory activities (for example, instrument life-cycle management).
+ Performs laboratory studies, projects, and processes/initiatives.
+ Assists in developing lab strategies, policies, and guidelines linked to area of expertise (for example, authoring Standard Operating Procedures).
+ Contributes to external and/or internal manuscripts, regulatory reports, and technical reports.
+ Supports equipment qualifications to ensure accuracy and consistency of results.
**QUALIFICATIONS**
**Education and Experience:**
+ Minimum Bachelors degree in Chemistry, Biochemistry or related Scientific discipline.
+ Recent graduate (2025 or due to graduate in 2026).
+ Technical troubleshooting and problem-solving skills.
+ Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
+ Be ambitious with excellent social, communication and partner management skills.
+ Acute attention to detail.
+ A focus on patients and customers at all times.
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Senior Manager, Quality Control Laboratory

Westport, Connacht AbbVie

Posted 2 days ago

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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 currently looking for a Senior Manager of Quality Control Laboratories to join our team in Westport on a 12-month fixed-term contract. The Senior Manager of Quality Control is responsible for strategy, planning, and management of laboratory operations, ensuring compliance with FDA, HPRA, and EPA safety standards and budgetary constraints. This role supports the QA site head in achieving operational goals.
Responsibilities:
+ Manage and motivate employees, ensuring capacity aligns with business needs.
+ Develop and deliver business plans, manage departmental budget, and handle new product implementation.
+ Represent the company in client and regulatory meetings, ensuring GMP compliance.
+ Organize cross-functional activities to improve lab efficiencies.
+ Coordinate meetings and manage documentation and compliance tools.
Qualifications
+ Proven track record in people and operations management within Pharma/Medical Devices/Food industry.
+ Qualification in Pharmaceutical Science.
+ Excellent conflict resolution, planning, and communication skills.
+ Ability to manage in regulated environments and adapt to changes.
+ Strong commitment to AbbVie's values and business ethics.
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:
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