Qualified Person (QP)
Location: Midlands, UK
Job Type: Permanent
Industry: Pharmaceutical Manufacturing
About the Role
A leading pharmaceutical manufacturer is seeking an experienced Qualified Person (QP) to join its Quality function. This is an excellent opportunity to play a key role in ensuring products are certified and released in compliance with UK and EU GMP requirements while supporting both commercial and investigational medicinal products.
The successful candidate will provide QP oversight across manufacturing operations, contribute to the Pharmaceutical Quality System, and work closely with cross-functional teams to maintain the highest standards of quality and compliance.
Key Responsibilities
- Act as a Qualified Person in accordance with EU GMP Annex 16 and applicable UK legislation.
- Certify commercial and investigational medicinal product batches for release.
- Ensure batches comply with Marketing Authorisations, Product Specifications, GMP requirements and Quality Technical Agreements.
- Review and approve Annual Product Reviews (APRs) and Product Quality Reviews (PQRs).
- Provide QP support to internal project teams and new product initiatives.
- Participate in customer meetings, technical discussions and project reviews.
- Represent Quality during customer audits, regulatory inspections and client visits.
- Review and approve Quality Technical Agreements with customers and external partners.
- Support the development and continuous improvement of the Pharmaceutical Quality System (PQS).
- Review and approve deviations, CAPAs, change controls, investigations and other key quality documentation.
- Contribute to quality risk management activities and continuous improvement initiatives.
- Participate in internal and external audit programmes.
- Maintain current knowledge of GMP regulations, Annex 16 requirements and industry best practices.
Requirements
- Eligible to act as a Qualified Person (QP) in the UK.
- Previous experience performing QP batch certification within a GMP pharmaceutical manufacturing environment.
- Strong knowledge of EU GMP , Annex 16 and pharmaceutical quality systems.
- Experience supporting commercial and/or investigational medicinal products.
- Proven experience reviewing quality documentation including deviations, CAPAs, change controls and investigations.
- Experience participating in regulatory inspections and customer audits.
- Excellent communication and stakeholder management skills.
- Strong attention to detail with a proactive, risk-based approach to quality.
Desirable Experience
- Experience within a Contract Development and Manufacturing Organisation (CDMO).
- Exposure to both commercial and clinical manufacturing.
- Experience reviewing Quality Technical Agreements.
- Broad understanding of pharmaceutical manufacturing operations and cross-functional quality support.
What's on Offer
- Permanent opportunity with a leading pharmaceutical manufacturer.
- High-impact role within an established Quality organisation.
- Exposure to both commercial and investigational products.
- Collaborative environment with opportunities to support global manufacturing programmes.
- Competitive salary and comprehensive benefits package.
