Excellent opportunity for a Qualified Person to join a leading biologics company in the West of Ireland. The Qualified Person will be responsible for releasing vaccine commercial products and have overall quality oversight in GMP compliance. The ideal candidate will already be a Qualified Person or have recently completed a QP qualification with a number of years experience in Quality Assurance operations.
Overview of your responsibilities (full job description available on request):
- Ensure each commercial batch meets Irish law, marketing authorisation, and EU GMP standards.
- Fulfill QP responsibilities
- Maintain detailed GMP knowledge for batch certification.
- Verify supply chain and quality systems across the product lifecycle.
- Confirm all manufacturing and testing sites comply with the MA.
- Ensure audits of all sites are completed and reports are available pre-certification
Knowledge, Skills and Experience Required for the Role:
- Qualified Person eligibility.
- Preferred experience as named QP in a licensed facility.
- Ideally, experience in sterile manufacturing or biotech.
- Skilled in cGMP application.
- Strong technical/compliance writing.
- Preferably with managerial experience.
- Experience with regulatory inspections and GMP audits.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062