Full job descriptionYour 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.