QP Outside IR35 - Sterile

Position: 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.