Sterility Assurance Specialist

1 month ago


Derbyshire, United Kingdom CK Group Full time

CK Group is seeking an experienced Sterility Assurance Specialist to join a leading pharmaceutical company near Burton-on-Trent.

The Role:

As a Sterility Assurance Specialist, you will be responsible for ensuring the implementation of effective sterility assurance and environmental monitoring programs in compliance with GMP regulations.

Key Responsibilities:

  • Develop and maintain sterility assurance practices and identify new technologies for microbiological testing and environmental control.
  • Oversee the QA team in delivering its objectives and design, implement, and maintain the quality management system.
  • Provide microbiological training and aseptic operator training for operational and quality staff.
  • Act as a technical approver and participate in compounding complaints investigation, non-conformance, and quality incidents investigation.

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 and experience of validation of microbiological methods or sanitisation processes.
  • Proven expertise in quality improvement and problem-solving skills.

What's on offer:

  • Private Healthcare cover.
  • Company Pension Scheme.
  • Life Assurance.
  • Gym Discount.
  • Access to Wellness platforms.


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