QA Specialist

We are looking for a QA Specialist to join our Quality Assurance team in Cork on a Fixed Term Contract until September 2027.

As a QA Specialist you will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations, with primary responsibility for the quality assurance operations activities in the Cork Site in relation to manufacturing and release of product.

Responsibilities:

• Review batch manufacturing data, systems, and documentation to confirm GMP compliance and support timely batch release.
• Verify bulk product labelling and contribute to the quality assessment of commercial finished products.
• Lead or support investigations into discrepancies, failures, quality events, and external complaints, ensuring effective CAPA follow-up.
• Review, write, and approve GMP documentation, including SOPs, reports, specifications, validation protocols, quality contracts, and exceptional documents.
• Support internal and supplier audits, conduct monthly GMP compliance walkdowns, and track actions through to closure.
• Manage change controls, complaints, and Product Quality Reviews (PQRs), while preparing QA metrics and communicating key issues to QA Operations leadership.
• Participate in compliance initiatives and support the preparation, execution, and follow-up of regulatory and client audits, as well as site inspections.
• Assist with the preparation and delivery of GMP training programs and presentations in line with internal procedures and applicable cGMP requirements.
• Represent QA on Business Excellence (BeX) projects, supporting GMP improvement, digital transformation.
• Ensure QA activities meet applicable health, safety, and regulatory requirements; support New Product Introduction (NPI) activities and contribute to the quality assessment of clinical, pre-commercial, and investigational medicinal products.

• Bachelor’s Degree in a related science based discipline.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge of GMP, good organisation skills and time management.
• Strong oral and written communication skills needed.
• Strong computer skills and knowledge of enterprise systems such as SolTraqs, EBR & SAP.

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.

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