Qualified Person
Collins McNicholas View all jobs
- Sligo
- Permanent
- Full-time
- 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
- 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