At a Glance
- Tasks: Lead sterility assurance and environmental monitoring in a GMP-regulated environment.
- Company: Established pharmaceutical manufacturer focused on product quality and patient safety.
- Benefits: Private healthcare, pension scheme, life assurance, gym discounts, and wellness access.
- Other info: Join a team dedicated to continuous improvement and professional growth.
- Why this job: Make a real impact on product quality and patient safety in a dynamic industry.
- Qualifications: Degree in Microbiology or related field with experience in aseptic manufacturing.
The predicted salary is between 55000 - 55000 £ per year.
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 will 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.
You will 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.
- Private Healthcare cover.
- Company Pension Scheme.
- Life Assurance.
- Gym Discount.
- Access to Wellness platforms.
- Yearly Pay Reviews.
If you are looking for an opportunity where your expertise in sterility assurance and microbiology will make a real difference, we would love to hear from you.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.
Sterility Assurance Specialist in Burton upon Trent employer: Talentmark
Join a leading pharmaceutical manufacturer near Burton upon Trent, where your expertise as a Sterility Assurance Specialist will be valued in a dynamic and supportive work environment. With a strong focus on employee growth, the company offers comprehensive benefits including private healthcare, a pension scheme, and wellness platforms, ensuring you thrive both personally and professionally. Embrace the opportunity to contribute to patient safety and product quality while being part of a culture that prioritises continuous improvement and innovation.
