Your Company
An established pharmaceutical manufacturing site is seeking an experienced Qualified Person (QP) to support batch release for commercial and clinical products.
This is a hands-on contracting role requiring a strong understanding of UK and EU GMP requirements, Annex 16, and quality leadership within a regulated manufacturing environment.
Key Responsibilities
- QP & Batch Certification
- Act as a named QP on the site MIA and IMP licences.
- Perform batch certification and release of commercial and clinical products in line with UK/EU GMP and Annex 16
- Confirm compliance of manufacturing steps either directly or through agreed delegation.
- Quality Operations & Oversight
- Provide QP oversight of GMP activities across manufacturing, packaging, and testing
- Support disposition of intermediates and finished products
- Provide quality input into deviations, OOS, change controls, and CAPAs
- Review and approve GMP documentation and operational procedures
Required Experience & Qualifications
- Eligible to act as a QP under UK/EU regulations
- Significant pharmaceutical manufacturing experience, ideally including sterile and/or biological products/ sterile manufacturing
- Proven experience with Annex 16 batch certification
About the role
On-site presence is required for 5 days, and we would consider 2 part-time FTEs.
Suitable for experienced QP contractors seeking a technically solid site with long-term potential
Rate:
£1,150/day
Location:
United Kingdom
IR35 Status:
Outside
Remote Status:
Onsite
Industry:
Science
Seniority Level:
Senior