Sterility Assurance Professional

1 month ago


Burton upon Trent, Staffordshire, United Kingdom CK Group Full time £40,000 - £45,000
The Role: CK Group are recruiting for a Sterility Assurance Specialist to join a pharmaceutical and life sciences company based in the UK. This is a permanent role, primarily on-site. The successful candidate will be responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in compliance with current GMP. This will involve protecting the end users of products manufactured in the compounding unit by maintaining an appropriate level of regulatory compliance.

Responsibilities:
  • Supporting sterility assurance practices and identifying/implementing new technology for microbiological testing and environmental control.
  • Overseeing the QA team in delivering its objectives and designing, implementing, and maintaining the quality management system.
  • Providing microbiological training and aseptic operator training for operational and quality staff, including periodic reassessment.
  • Acting as a technical approver and participating in compounding complaints investigation, non-conformance, and quality incidents investigation.
  • Qualifying, auditing, and monitoring the service levels of external labs and providing proper oversight on technical aspects.

Your Background:
  • Degree qualified in Microbiology or equivalent with industry experience.
  • Experience of microbiology in an aseptic facility with strong operational experience in an aseptic manufacturing background.
  • Hands-on expertise in aseptic techniques.
  • Experience of validation of microbiological methods or sanitisation processes.
  • Proven expertise in quality improvement and problem-solving skills.

What's on offer:
  • A basic salary of £40,000 - £45,000 DOE.
  • Private Healthcare cover.
  • Company Pension Scheme.
  • Life Assurance.
  • Gym Discount.
  • Access to Wellness platforms.


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