Quality Assurance Specialist

4 weeks ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time
Quality Specialist

At PCI Pharma Services, we are committed to delivering high-quality products and services to our customers. We are seeking a highly skilled Quality Specialist to join our team.

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 culture of quality throughout the site business units to improve manufacturing, development, and clinical performance.
  • Conduct performance audits and follow up on actions within site business units.
  • Review and approve Master Batch Records, master dispatch job cards, technical specifications, and other critical documents.
  • Write and review Drug Product Files and Product Specification Files.
  • QA approval of Item Masters.
  • Batch record compilation and regulatory checks.
  • Interpret PQR data.
  • Review and approve deviations and change controls as needed.
  • Identify and address non-compliance issues and initiate quality improvements.
  • Ensure products proposed for release meet license requirements, clinical trial applications, and cGMP.
  • Assist with GMP training within the department and cross-site.
Benefits:
  • Competitive salaries and benefits package.
  • Generous annual leave and bank holidays.
  • Family-friendly benefits and employee referral scheme.
  • Staff engagement and recognition schemes.
  • Health and well-being support, including sick pay, access to a 24/7 GP, mental health support, and life assurance.
  • On-site subsidized canteen and cycle-to-work scheme.
  • Development opportunities, including training programs, coaching, and further education options.

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