Quality Assurance Specialist

2 weeks ago

Tredegar, Blaenau Gwent, 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 Quality Assurance Specialist, you will play a critical role in ensuring the excellence and regulatory compliance of our operations.

The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in interpreting and applying business and regulatory guidelines. You will be responsible for providing technical quality support to our operational departments, reviewing and approving deviations and change controls, and addressing non-compliance issues.

Main responsibilities:

  • Provide technical quality support to operational departments for new and ongoing projects.
  • Lead the interpretation of business and regulatory guidelines to ensure regulatory compliance.
  • Promote a sense of quality throughout the site business units to raise manufacturing/development/clinical performance and eliminate waste caused by unnecessary compliance errors.
  • Conduct performance audits and follow up on actions within site business units.
  • Review and approve Master Batch Records (MBR), master dispatch job cards, Technical Specifications, and addendums.
  • Write and review Drug Product Files (DPFs) and Product Specification Files (PSFs).
  • QA approval of Item Masters.
  • Batch record compilation and regulatory checks.
  • Interpret PQR data.
  • Review and approve Deviations and Change Controls as needed.
  • Review non-compliance identified by audit, deviations, and complaints, and use technical/professional judgment to make the appropriate product quality decisions.
  • Ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application, and cGMP.
  • Assist with GMP training within the department and cross-site.

We offer a competitive salary, generous annual leave, and a range of benefits designed to support your well-being and enhance your overall quality of life. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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