Sterility Assurance Specialist

Sterility Assurance Specialist (V-194020)

Location: Burton upon Trent, England
Sector: Pharmaceuticals
Salary: £50,000.00 to £60,000.00 per annum

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.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.