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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
General Purpose of Role
To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.
Main Responsibilities
1. Review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation (or other relevant documentation).
2. Review Batch Documents for all operations performed at PCI Pharma Services.
3. Certify Medicinal Products for use in the UK, EU, and outside the EU (where relevant).
4. Undertake audits in the UK, EU, and third countries to ensure manufacturing sites operate in compliance with EU GMP.
5. Provide advice and guidance to PCI staff and customers regarding QP requirements within the UK and EU.
6. Stay updated with the requirements of Medicines Authorities across the UK, EU, and other relevant regions.
7. Review PCI Project Files (PSFs, commercial project files, etc.) to ensure compliance with current regulatory requirements and PCI procedures.
8. Contribute to the Quality Management System (QMS) at PCI.
9. Assist with regulatory inspections and client audits.
10. Perform Supply Chain Oversight when required.
Specific Qualifications
Eligible to act as a Qualified Person (QP) for certification of Marketed Products and Investigational Medicinal Products in accordance with UK legislation and EU directives 2001/83/EC and 2001/20/EC.
Previous Work Experience
Experience as a QP certifying sterile medicinal products, particularly Biopharmaceuticals manufactured aseptically.
Knowledge / Skills Competence
* Extensive QA experience in the medicinal products/pharmaceutical industry.
* GMP audit experience, preferably as a Lead Auditor.
* Experience in Biopharmaceuticals.
* Experience in sterile manufacture.
* Good IT skills (e.g., MS Word).
Join us and be part of building the bridge between life-changing therapies and patients.
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Created on 26/04/2025 by TN United Kingdom
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