Senior Quality Assurance Specialist
Location: Dublin
Contract: Full-time, permanent
The Opportunity
We are partnering with a global pharmaceutical organisation to appoint a Senior QA Specialist to support quality operations across international markets. This role sits within a growing quality function and offers broad exposure across commercial, distribution, supplier, and compliance activities at a regional or global level.
The successful candidate will play a key role in maintaining and enhancing the Pharmaceutical Quality System, working closely with internal stakeholders and external partners to ensure ongoing cGxP compliance.
Key Responsibilities
- Support day-to-day Quality Assurance operations across commercial and clinical products
- Provide QA oversight for manufacturing, distribution, and pharmacovigilance activities
- Provide Quality oversight of Contract Manufacturing Organisations (CMOs) and third-party suppliers
- Review and approve product quality investigations and associated CAPAs
- Support supplier qualification and maintenance of the Approved Supplier List
- Coordinate and support internal and external audits, including follow-up actions
- Support drafting, review, and maintenance of Quality Agreements
- Compile Annual Product Quality Reviews (APQRs)
- Support regulatory inspections, renewals, and responses to compliance queries
- Contribute to continuous improvement and risk management activities
- Build effective working relationships with Quality partners across the supply network
Candidate Profile
- Bachelor's degree in a scientific discipline
- 5-7 plus years in quality assurance in pharmaceutical or biopharma manufacturing
- Strong working knowledge of GMP and GDP requirements
- Experience supporting investigations, deviations, CAPA, and product complaints
- Exposure to solid oral dosage and/or liquid dosage manufacturing and packaging
- Experience working with CMOs and external suppliers in a QA capacity
- RP / DRP experience is a distinct advantage
- Comfortable interpreting regulations and making quality decisions with appropriate governance
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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