Blackfield Associates is partnered with a leading pharmaceutical company based in Cheshire in the search for a Qualified Person.
As a Qualified Person, you will be responsible for batch certification and release (commercial & clinical) under UK and EU GMP and Annex 16, ensuring compliance with regulatory requirements and Quality Technical Agreements. You will provide QA leadership across sterile manufacturing, oversee GMP elements of product development, including clinical material, and support a strong commitment to quality across site operations.
Key technical responsibilities include:
* Acting as a named Qualified Person on MIA and IMP licences, certifying and releasing commercial and clinical batches in line with UK/EU GMP and Annex 16.
* Providing QA leadership and oversight across sterile manufacturing operations to ensure ongoing regulatory compliance.
* Performing quality review and approval of manufacturing data, APQRs, deviations, CAPA, change control, and regulatory submissions.
* Supporting internal audits, regulatory inspections, and providing GMP oversight for CMOs and external partners.
The correct candidate for this opportunity will be an eligible Qualified Person with extensive experience in sterile manufacturing and Quality Assurance. They will have demonstrable experience acting as a named QP on MIA and IMP licences, leading batch certification and release activities, and providing quality oversight across technical operations. A degree in a relevant scientific discipline is essential, and experience with Lean/Six Sigma or Lead Auditor certification is desirable.