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Sterility Assurance Specialist

CK Group- Science, Clinical and Technical
Posted a day ago, valid for 23 days
Location

Burton-On-Trent, Staffordshire DE14 2PZ, England

Salary

£40,000 - £45,000 per annum

Contract type

Full Time

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Sonic Summary

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  • CK Group is seeking an experienced Sterility Assurance Specialist for a pharmaceutical and life sciences company near Burton-on-Trent.
  • The role requires a degree in Microbiology or equivalent, along with industry experience in aseptic manufacturing and microbiology.
  • Candidates should have hands-on expertise in aseptic techniques and experience in validating microbiological methods or sanitation processes.
  • The position offers a salary ranging from £40,000 to £45,000 depending on experience, along with benefits such as private healthcare and a company pension scheme.
  • This is a permanent, primarily on-site role focused on ensuring compliance with GMP and overseeing sterility assurance practices.
CK Group are recruiting for an experienced Sterility Assurance Specialist, with industry aseptic manufacturing background, to join a pharmaceutical and life sciences company based near Burton-on-Trent, on a permanent basis. This role will be primarily on-site.


The Role:

Exciting new role within the team, where you will be responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in compliance with current GMP. You will protect the end users of products manufactured in the compounding unit by maintaining an appropriate level of regulatory compliance.


Responsibilities:
  • Supporting sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
  • Oversee the QA team in delivering its objectives and to design, implement and maintain the quality management system.
  • Providing microbiological training and aseptic operator training for operational and quality staff including periodic reassessment.
  • Act as a technical approver and participate in compounding complaints investigation, non-conformance and quality incidents investigation.
  • Qualification, auditing and monitoring the service Levels of external Lab, providing the proper oversight on technical aspects.

Your Background:
  • Degree qualified in Microbiology or equivalent with industry experience.
  • Experience of microbiology experience 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.


Apply:


It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.

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