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Quality Assurance Specialist

2 months ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at PCI Pharma Services. As a key player in ensuring excellence and regulatory compliance, you will provide vital technical quality support for both new and ongoing projects, interpreting and applying business and regulatory guidelines.

Main Responsibilities
  • Provide technical Quality support to the Operational departments for new and ongoing projects.
  • Lead the interpretation of business and regulatory (EU/US/Japan) 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 despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
  • Write and review Drug Product Files (DPFs), 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 (in association with site QP's), and to initiate and promote quality improvements to prevent re-occurrence.
  • 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.
What We Offer
  • Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
  • Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
  • Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
  • Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
  • Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you.
  • Staff Engagement: We value your dedication with recognition schemes and long-service awards.
  • Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
  • On-Site Subsidized Canteen.
  • Cycle to Work Scheme.
  • Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.