QP Contract Outside IR35 - Sterile

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
  
  Please click "apply now" to send an updated CV to Julia Bowden at Hays.