We have a Qualified Person position working for a Biologics company in the west of Ireland. Reporting to the Quality Manager, the Qualified Person (QP) will be accountable for providing strong Quality Assurance oversight of commercial vaccine products. This role is responsible for quality oversight and batch certification of finished products within the scope of the company’s Manufacturing and Importation Authorisation (MIA), as well as for fulfilling all statutory duties of the Qualified Person in accordance with applicable EU regulations.
Overview of your responsibilities (full job description available on request):
- Ensure each commercial batch is manufactured, tested, and released in compliance with Irish law, the relevant Marketing Authorisation (MA), EU GMP, and Annex 16 requirements
- Fulfil the ethical, professional, and legal responsibilities of the Qualified Person in line with EU Regulations
- Maintain in-depth knowledge of all GMP manufacturing steps under QP responsibility for batch certification
- Verify the end-to-end supply chain and robustness of pharmaceutical quality systems through final batch certification, including materials, packaging, and critical suppliers, using audit and risk-based approaches
- Confirm all manufacturing, testing, and certification sites comply with the MA and operate in line with approved processes
- Ensure all required audits of manufacturing and testing sites, including active substance manufacture, are completed and available prior to batch certification
- Confirm all post-marketing regulatory commitments related to manufacturing or testing have been fulfilled
Knowledge, Skills and Experience Required for the Role:
- Prior experience as a named Qualified Person (QP) at a licensed facility preferred
- Background in sterile manufacturing and/or biotechnology preferred
- Strong working knowledge of cGMP in manufacturing and testing environments
- Clear, accurate technical and compliance-focused writing skills
- People management or supervisory experience preferred
- Experience supporting regulatory inspections and internal GMP audits
- Proven ability to manage stakeholders and escalate issues appropriately
For a confidential discussion and more information on the role contact Courtney Russell.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
