Senior Quality Assurance Specialist

1 week ago

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

Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI Pharma Services.

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 certify manufacturing processes/activities performed under PCI Pharma Services MHRA licenses.

Main Responsibilities:

  • Review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorization.
  • 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.
  • 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 the world.
  • Review PCI Project Files to ensure compliance with current regulatory requirements and PCI procedures.
  • Provide input and assistance with relevant elements of the Quality Management System at PCI.
  • Assistance with regulatory inspections and client audits.
  • Perform Supply Chain Oversight when required.

Specific Qualifications:

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.

Previous Work Experience:

Experience working as a QP in the certification of sterile medicinal products, particularly Biopharmaceuticals manufactured aseptically.

Specific Knowledge/Skills/Competence:

  • 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).

Be part of building the bridge between life-changing therapies and patients.

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