Sterility Assurance Specialist
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 108 122 in all correspondence.