Sterility Assurance Specialist

Talentmark

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.
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.
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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