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.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 ReviewsIf 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 (Apply online only) in all correspondence