Talentmark
Sterility Assurance Specialist
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Sterility Assurance Specialist
Sterility Assurance Specialist
Near Burton upon Trent | On-site | Pharmaceutical Manufacturing
Talentmark is partnering with an established pharmaceutical manufacturer to recruit a Sterility Assurance Specialist. This is an excellent opportunity for an experienced microbiologist or sterility assurance professional with aseptic production experience to play a key role in safeguarding product quality and patient safety within a GMP-regulated aseptic manufacturing environment.
Working as the site's sterility assurance expert, you'll help strengthen quality systems, lead microbiological initiatives, and support the development of a growing microbiology function.
Key Responsibilities
- Lead and maintain sterility assurance and environmental monitoring programmes in line with GMP requirements.
- Act as the site subject matter expert for microbiology and sterility assurance.
- Investigate deviations, non-conformances, environmental monitoring excursions, and complaints.
- Analyse and trend microbiological and environmental monitoring data to identify risks and opportunities for improvement.
- Support validation activities, including microbiological methods and sanitisation processes.
- Manage external laboratory relationships and oversee testing programmes.
- Develop and maintain quality documentation, SOPs, and technical procedures.
- Deliver microbiology and aseptic technique training across the business.
- Drive continuous improvement initiatives to strengthen quality and compliance.
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Your Background:
You'll bring experience from a sterile pharmaceutical, healthcare, or aseptic manufacturing environment and be passionate about maintaining the highest standards of product quality.
- A degree in Microbiology or a related scientific discipline (or equivalent experience).
- Strong operational experience in sterility assurance within a GMP-regulated aseptic environment.
- Strong knowledge of environmental monitoring programmes and microbiological quality systems.
- Experience investigating deviations, out-of-specification, or out-of-limit results.
- A good understanding of GMP and pharmaceutical regulatory requirements.
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Benefits
- Private Healthcare cover.
- Company Pension Scheme.
- Life Assurance.
- Gym Discount.
- Access to Wellness platforms.
- Yearly Pay Reviews
If you're looking for an opportunity where your expertise in sterility assurance and microbiology will make a real difference, we'd love to hear from you.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 194 020 in all correspondence.
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