Qualified Person (QP)

Qualified Person (QP)

Walker Cole International is supporting a leading pharmaceutical manufacturing organisation in the North West in the search for a Qualified Person (QP) to join their Quality Assurance team.

This is an opportunity to join a growing GMP site, playing a key role in ensuring product quality and patient safety across both commercial and clinical supply.

As the Qualified Person, you will:

• Certify and release medicinal product batches in line with UK/EU GMP and Annex 16
• Lead batch disposition activities, ensuring timely and compliant product release
• Provide QA leadership across manufacturing, technical and supply chain teams
• Act as an SME during regulatory inspections, audits and external partner interactions
• Drive continuous improvement initiatives to enhance site quality performance

The Qualified Person will have:

• Degree in a relevant scientific discipline (e.g. Chemistry, Pharmacy, Biology)
• Strong GMP knowledge, including Annex 1 and Annex 16
• Proven experience within pharmaceutical manufacturing (ideally sterile environments)
• Strong communication and stakeholder management skills

Qualified Person | QP | GMP | Good Manufacturing Practice | Annex 1 | Annex 16 | Batch Release | Batch Certification | Pharmaceutical Manufacturing | Sterile Manufacturing | Aseptic | Quality Assurance | QA | IMP | Investigational Medicinal Product | MIA Licence | QP Release | EU GMP | UK GMP | Regulatory Compliance | Quality Systems | Audit | Inspection | CMO | Continuous Improvement | Lean | Six Sigma | Biopharmaceutical | Sterile Products | Quality Leadership