BGD Qualified Person
1 week ago
Transforming lives through innovative therapies and global impact. At PCI Pharma Services, we bridge the gap between life-changing treatments and patients worldwide.
Our Mission
We invest in people who drive progress, create a better tomorrow, and shape the future of our industry.
Job Summary
To certify manufacturing processes and activities performed under PCI Pharma Services MHRA licenses, ensuring compliance with UK and EU GMP and product specifications.
Main Responsibilities
- Review Batch Manufacturing Documents for compliance with UK and EU GMP and product specifications.
- Review Batch Documents for all operations performed at PCI Pharma Services.
- Certify medicinal products for use in the UK, EU, and outside the EU.
- Conduct audits in the UK, EU, and third countries to ensure compliance with EU GMP.
- Provide advice and guidance on QP requirements within the UK and EU.
- Stay up-to-date with regulatory requirements across the UK, EU, and rest of the world.
- Review PCI Project Files to ensure compliance with current regulatory requirements and PCI procedures.
- Contribute to the Quality Management System at PCI.
- Assist with regulatory inspections and client audits.
- Perform Supply Chain Oversight when required.
Requirements
Eligibility to act as a Qualified Person (QP) for the certification of marketed products and investigational medicinal products in accordance with UK legislation and EU directives.
Desirable Qualifications
Experience working as a QP in the certification of sterile medicinal products, particularly biopharmaceuticals manufactured aseptically.
Key Skills
- Extensive QA experience within the medicinal products/pharmaceutical industry.
- GMP audit experience, preferably as a Lead Auditor.
- Experience in biopharmaceuticals and sterile manufacture.
- Effective communication skills.
- Good IT skills, including MS Word.
Be part of building the bridge between life-changing therapies and patients.
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