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8 Pfizer jobs in Cork

Quality Assurance Specialist

Cork, Munster Catalyx

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Job Description

Catalyx is seeking a Quality Assurance Specialist to join our team and work on our customer site in Cork. This role operates on a rotating weekly shift pattern, alternating between morning and evening shifts. 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: Provide quality oversight across various production stages, including material inspection, in-process control, and product readiness activities. Assemble and review documentation to support product disposition, working closely with operational and quality colleagues to meet release timelines. Support packaging operations by conducting visual inspections and ensuring process adherence during routine activities. Collaborate with cross-functional teams (Manufacturing, Quality Control, Supply Chain, Engineering, etc.) to resolve day-to-day queries and issues efficiently. Contribute to the maintenance and improvement of quality systems through change control, deviation management, and CAPA oversight. Conduct documentation reviews such as batch records, SOPs, and WI updates, ensuring alignment with regulatory and internal standards. Participate in the preparation of periodic quality reports and metrics, supporting trend identification and ongoing improvement. Engage in internal audits and readiness assessments to ensure site and process compliance. Provide knowledge-sharing and informal coaching on quality processes to enable operational teams to work effectively within GMP frameworks. Support project-based work and initiatives aimed at process enhancement and improved compliance practices. Review and approve manufacturing inputs and documents to ensure compliance with release criteria. Requirements: Bachelor's degree in a scientific or technical discipline. Minimum 3 years' experience in a Quality or GMP-related role within the pharmaceutical, biotech or related regulated sector. Familiarity with batch documentation, quality systems, and regulatory expectations (e.g., FDA, EMA). Ability to analyse issues, identify appropriate corrective actions, and escalate where necessary. Experience supporting or interacting with packaging or material management processes is beneficial. Strong written and verbal communication skills; confident working in a collaborative environment. Competence with Microsoft Office tools, particularly Excel and Word. Organised, detail-focused, and capable of managing multiple priorities. Comfortable working independently within defined parameters, and adaptable to shifting project needs 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.

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Quality Assurance Analyst

Cork, Munster Clearstream Fund Centre S.A., Cork Branch

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Job Description

Build the future of financial markets. Build yours. Ready to make a real impact in the financial industry? At Deutsche Brse Group, we'll empower you to grow your career in a supportive and inclusive environment. With our unique business model, driven by 15,000 colleagues around the globe, we actively shape the future of financial markets. Join our One Global Team! Who we are Deutsche Brse Group is one of the world's leading exchange organisations and an innovative market infrastructure provider. With our products and services, we ensure that capital markets are fair, transparent, reliable, and stable. Together, we develop state-of-the-art IT solutions and offer our IT systems all over the world. Within the Deutsche Brse Group, Clearstream is an international central securities depository (ICSD). It provides post-trade infrastructure and securities services for the international market and 59 domestic markets worldwide, with customers in 110 countries. Cork Your career at Deutsche Brse Group Your area of work The Quality Control Officer is responsible for ensuring the accuracy, consistency, and completeness of regulatory reporting outputs across KIIDs, PRIIPs and ESG domains. This role supports the delivery of high-quality reports by performing detailed quality checks, identifying discrepancies, and driving continuous improvement in data validation and reporting processes. Your responsibilities Perform detailed quality control checks on KIIDs, PRIIPs and ESG reports prior to client delivery, ensuring alignment with regulatory standards and internal quality benchmarks. Identify and document errors, inconsistencies, and missing narratives across reporting outputs. Collaborate with Regulatory Reporting Agents to validate data sources and ensure accurate interpretation of regulatory requirements. Monitor and report on recurring quality issues, contributing to root cause analysis and recommending corrective actions. Support the enhancement of validation tools and processes to reduce false positives and improve reporting accuracy. Maintain quality logs and KPIs to track performance and support post-production reviews. Liaise with internal teams to ensure timely resolution of quality issues and escalate critical findings to management. Assist in the development and implementation of quality assurance procedures and best practices. Participate in assigned training and stay updated on regulatory changes impacting reporting standards. Act and work in compliance with all internal rules and policies. Your profile A minimum of 3 years of post-graduate education, preferably in Finance, Data Management, or a related field At least 2 years of experience in a quality assurance, data validation, or regulatory reporting role Understanding of ESG, KIID, and PRIIPs reporting standards and regulatory frameworks Proficiency in English; additional languages are an asset Advanced Microsoft Excel skills and familiarity with data validation tools Excellent attention to detail and analytical skills Strong communication and interpersonal skills Proactive, solution-oriented mindset with a collaborative approach Ability to work independently and manage multiple priorities

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Quality Assurance Associate

Cork, Munster Life Science Recruitment Ltd

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Job Description

Job title:Quality Assurance Associate Location:Bishopstown, Cork. Benefits:Excellent salary, 10% bonus, hybrid working, healthcare and pension. Company: My client, spun out from Munster Technological University (formerly Cork Institute of Technology) in 2015, develops innovative ENT (Ear, Nose, and Throat) medical devices that simplify surgical procedures by enabling treatments to be conducted safely outside the operating roomtypically with just topical anesthesia. Role: You will be responsible for assisting in the maintenance of the Quality Management System (QMS), assist with the management of internal processes and external vendors to ensure product quality. This involves managing supplier relationships, participating in audits, resolving quality issues, driving continuous improvement initiatives and collaborate with various teams to maintain quality across the supply chain. The person in this position must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. Job Requirements: Maintaining the effectiveness of the QMS and making continuous improvements to it. Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements. Responsible for assisting in notified body audits and internal audits. Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates. Support the wider team to ensure product manufacture and testing meets the requirements. Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards. Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions. Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns. Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: coordinating investigations between complainants and contract manufacturing sites follow up on corrective actions, when required Support with Significant Changes and Notified Body interactions. Carry out other quality related duties as required, inclusive of updates to procedures, forms, processes and periodic reviews. Education Bachelors degree in engineering or science. Quality certification in ISO 13485 a must. A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation. Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820. Desirable to have lead auditor certification and/or Regulatory certifications. Proven track record with the ability to successfully manage projects to deadlines. Good Documentation Practice experience. Report & Technical Writing experience. Project Management experience. Strong ability to manage critical projects as part of an interdisciplinary team. Excellent problem solving and communication skills. Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Healthcare + Annual Bonus + Pension

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Senior Quality Assurance Specialist

Cork, Munster Morgan McKinley

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Job Description

Senior Quality Assurance Specialist Location: Cork Industry: Pharmaceutical Employment Type: Full-Time Our client, a leading global pharmaceutical organization, is seeking a Senior Quality Assurance (QA) Specialist to join their dynamic team. This is a fantastic opportunity for an experienced QA professional to work in a high-impact, compliance-driven environment and play a pivotal role in ensuring product quality throughout the lifecycle. Key Responsibilities: Ensure full cGMP compliance in all project- and product-related activities and systems. Develop and implement quality policies, procedures, and continuous improvement initiatives. Support supplier qualification processes and collaborate closely with Procurement and external partners to ensure quality standards are met. Lead and manage all quality aspects of assigned projects and products, ensuring compliance with regulatory and internal standards. Oversee a broad range of QA-related areas such as: -Raw materials, supplier management, production processes -Specifications, change control, deviations, CAPA -Batch release, cleaning validation, audits, and customer complaints -Quality documentation, stability programs, regulatory compliance Provide quality support for the introduction of new products, including document review and approval. Ensure that all activities comply with Health, Safety, and Environmental standards. Be present on the manufacturing floor to offer real-time support and oversight. Qualifications & Experience: Bachelor's degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering 5 years of QA experience in a GMP-regulated pharmaceutical environment - mandatory Hands-on experience in a GMP operational setting Strong knowledge of GMP standards and regulatory requirements

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Quality Assurance Functional Test Engineer

Tralee, Munster NTT DATA North America

Posted 6 days ago

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Job Description

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.
**Summary**
We are seeking an experienced Quality Assurance Functional Test Engineer to join our team. This person will provide quality assurance testing for corporate banking applications to ensure any business-requested changes are validated prior to handing off to UAT. You will learn the business as well as understand the testing framework and processes for the applications. You will be required to draw on testing knowledge in order to creatively develop solutions for automating test processes as well as design maintenance procedures and documentation. Within this team, there is an open and collaborative approach to work on solutions for applications and workflow processes. Additionally, you will be required to automate any repetitive steps in a workflow process or application in order to provide the highest quality for our technology and business and will be required to meet those standards and provide the best test capabilities.
**Experience**
+ Excellent problem solving and analytical skills with 7 to 9 years of experience.
+ Experience working in corporate banking domain/applications is a must.
+ Conversant in ITIL
+ Should be able to prepare automation strategy and plan and develop data reconciliation automations
+ Experience in designing Frameworks is a must
+ Good knowledge in any automation testing tools
+ Should have worked on defect management tools like QC or Jira
+ Extensive hands-on experience in Database, Data Warehouse (ETL), Data conversion, data migration, functional/regression, back/front end and API testing.
+ Should be a good leader in driving QA projects
+ Playwright Experience will be added advantage
**About NTT DATA**
NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com ( DATA endeavors to make_ _ _accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at_ _ _. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click_ here ( _. If you'd like more information on your EEO rights under the law, please click_ here ( _. For Pay Transparency information, please click_ here ( **_._**
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Senior Manager, Quality Assurance, New Product Introduction

Cork, Munster Stryker

Posted 5 days ago

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Job Description

**Senior Manager Quality Assurance, New Product Introduction (NPI)**
**Strategic QA leader** with a passion for people, innovation, and excellence. We're looking for someone who thrives at the intersection of **quality and transformation** , and who's ready to shape the future through enabling technology platforms and innovative supply chain solutions alongside our **AMagine partners** . A Passionate Quality Leader who will lead the execution of **quality strategies** for New Product Introductions (NPI), with a strong focus on **speed-to-market, risk mitigation** , and **compliance** .
**Position Summary**
As a global partner & leader of the Quality Assurance (QA) AMagine and NPI team, this role advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches and in the Personalised Solutions space. This leader will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch.
Inspires NPI team in partnering to drive robust preventative measures and improvements of product quality and process design.
**Position Requirements**
Working within the regional NPI Quality structure, in a leadership capacity, has responsibility for quality related activities, including, but not limited to the following:
+ **Sets direction:** Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.
+ **Builds organizational capability:** Promotes the optimisation of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit.
+ **Inspires others** : Coaching and development of staff who champion quality assurance during the product development process, ensuring product launches meet or exceed established metrics.
+ **Delivers results:** Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
+ Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability.
+ Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch.
+ Collaborate with Regional NPI QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global NPI QA team.
+ Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI project goals as well as the regulatory requirements.
+ Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets per the design

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Senior Manager, Quality Assurance, New Product Introduction

Cork, Munster Stryker Ireland

Posted today

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Job Description

Senior Manager Quality Assurance, New Product Introduction (NPI) Strategic QA leader with a passion for people, innovation, and excellence. We're looking for someone who thrives at the intersection of quality and transformation, and who's ready to shape the future through enabling technology platforms and innovative supply chain solutions alongside our AMagine partners. A Passionate Quality Leader who will lead the execution of quality strategies for New Product Introductions (NPI), with a strong focus on speed-to-market, risk mitigation, and compliance. Position Summary As a global partner & leader of the Quality Assurance (QA) AMagine and NPI team, this role advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches and in the Personalised Solutions space. This leader will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch. Inspires NPI team in partnering to drive robust preventative measures and improvements of product quality and process design. Position Requirements Working within the regional NPI Quality structure, in a leadership capacity, has responsibility for quality related activities, including, but not limited to the following: Sets direction: Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability. Builds organizational capability: Promotes the optimisation of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit. Inspires others: Coaching and development of staff who champion quality assurance during the product development process, ensuring product launches meet or exceed established metrics. Delivers results: Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process. Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability. Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch. Collaborate with Regional NPI QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global NPI QA team. Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI project goals as well as the regulatory requirements. Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets per the design

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Associate Director - Computer System Quality Assurance & Site Data Lead

Cork, Munster €150000 - €200000 Annually Eli Lilly and Company

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Job Description

permanent

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are looking for a highly motivated and detail-oriented CSQA Associate Director to join our quality assurance team. The selected candidate will be responsible for ensuring the highest standards of product quality and compliance for our electronic systems and data integrity requirements.

The Associate Director - Computer Systems Quality Assurance & Data Integrity will play a critical role in developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. The individual will be responsible for ensuring the quality, integrity, and compliance of GxP computerized systems, including manufacturing, warehouse and laboratory systems. The role focuses on implementing robust data governance practices, executing computer system validation (CSV), supporting laboratory informatics systems (e.g., LIMS, CDS, ELN), warehouse and manufacturing systems (MES, DeltaV, etc.), and driving compliance with global regulatory expectations. This leadership position will work closely with cross-functional teams and supports inspections, continuous improvement, and quality culture development at the site and global level.

Key Responsibilities:

Quality Systems and Data Integrity:

• Implement Global CS and DI Quality Standards to the new Lilly Limerick site.
• Provide quality direction and governance for QA-owned e-systems, site IT systems, manufacturing systems and site laboratory systems.
• Develop and maintain quality assurance procedures, policies, and systems related to data management, and CSV.
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices), Data Integrity and other relevant regulations.
• Participate in IT and quality organizations to provide consistency across all computer systems areas.
• Perform and support data flow mapping for production, analytical, and site-wide processes.
• Ensure accurate documentation of quality records, validation activities, and system-related compliance data.
• Oversee system change control, deviation management, CAPA, and system periodic review processes.
• Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
• Develop and implement comprehensive data governance frameworks to ensure data quality, consistency, and integrity throughout its lifecycle.
• Lead data mapping and flow assessments across lab, manufacturing, and support functions.
• Collaborate with data owners and functional teams to establish and monitor data integrity KPIs.
• Perform risk assessments and inspections to identify and mitigate data integrity vulnerabilities.
• Provide QA oversight for manufacturing (MES, DeltaV, DCS), laboratory (LIMS, ELN, and benchtop instruments) and logistics systems (SAP, EWM etc.).
• Ensure systems are qualified, validated, and remain in a compliant state per regulatory expectations.
• Support automation initiatives and integration with enterprise systems.
• Review and approve system validation documents, including URS, IQ/OQ/PQ, periodic reviews, and change controls.

Computer System Validation (CSV):

• Ensure all GxP computerized systems meet CSV requirements and are aligned with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Oversee validation lifecycle from planning through retirement, ensuring traceability and compliance.
• Provide QA review and approval for CSV deliverables, deviations, and risk-based validation strategies.

Regulatory Compliance & Inspection Readiness:

Act as a site data lead, serve as Quality SME for data integrity and systems during internal and external inspections.
• Maintain inspection readiness across all supported systems, ensuring alignment with corporate and regulatory standards.
• Stay current with industry regulations, guidelines, and best practices.
• Interpret evolving regulations and ensure site policies and procedures are kept current and aligned.
• Assist in the preparation and execution of regulatory inspections and audits.
• Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for IT systems.
• Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP IT systems.

Continuous Improvement & Strategy:

• Identify areas for optimization in data flow, system integration, and validation strategies.
• Champion initiatives in digital transformation, data contextualization, and visualization to enhance decision-making and compliance.
• Align site and global system strategies and contribute to data governance networks.

Training & Leadership:

• Deliver training on data integrity principles, laboratory and computer system compliance, and validation methodologies.
• Mentor team members and functional stakeholders to build local capability in data management and CSV.
• Support talent development and promote a strong compliance culture.

Education:

• Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality or a related discipline.
• Advanced degrees (e.g., MSc, PhD) are desirable.

Experience:

• 10+ years with leadership in quality, compliance, data governance, and lab systems validation and quality assurance.

Required Skills:

• Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements.
• Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation.
• Proficiency with validation frameworks (e.g., GAMP 5), risk management, and audit readiness.
• Experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS).
• Exceptional communication, cross-functional leadership, and decision-making abilities.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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8 Pfizer jobs in Cork

Quality Assurance Specialist

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Quality Assurance Analyst

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Quality Assurance Associate

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Senior Quality Assurance Specialist

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Quality Assurance Functional Test Engineer

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Senior Manager, Quality Assurance, New Product Introduction

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Senior Manager, Quality Assurance, New Product Introduction

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Associate Director - Computer System Quality Assurance & Site Data Lead

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