Senior Quality Assurance Specialist

7 days ago

Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

At PCI Pharma Services, we are committed to delivering life-changing therapies to patients around the world. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.

Main Responsibilities:

  • Review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation.
  • Review Batch Documents for all operations performed at PCI Pharma Services.
  • Certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
  • Undertake audits in the UK, EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
  • Provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
  • Keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).
  • Review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
  • Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
  • Assistance with regulatory inspections and client audits.
  • Perform Supply Chain Oversight when required.

Requirements:

  • Eligible 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 2001/83/EC and 2001/20/EC respectively.
  • Experience working as a QP in the certification of sterile medicinal products in particular Biopharmaceuticals manufactured aseptically.
  • Extensive QA experience within the medicinal products/pharmaceutical industry.
  • GMP Audit experience preferably qualified as Lead Auditor.
  • Experience in Biopharmaceuticals.
  • Experience in Sterile manufacture.
  • Effective Communication skills.
  • Good IT skills (at least MS Word).

We are PCI Pharma Services, and we are committed to building the bridge between life-changing therapies and patients.

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