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
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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