Sterility Assurance Team Leader – Full Time –


Leading International Pharmaceutical Manufacturer seeks an experienced Sterility Assurance Team Leader.

About the role:
You will be responsible for providing technical expertise and supporting our aseptic compounding unit on all sterility assurance aspects. You will be a valuable and effective source of information and advice on sterility assurance and will positively contribute to the Quality Management Team and site, ensuring that the site maintains a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy and current industry trends. Reporting to the Head of Quality you will work with the existing Environmental Monitoring team, as well as sterility assurance colleagues in other manufacturing and global units.

Skills and experience:

Demonstrated leadership, interpersonal and influence skills in pharmaceutical industry (specifically specials manufacture) or medical devices, with the proven ability to teach and coach individuals from diverse backgrounds with varying communication and technical skills.
A microbiology graduate with significant experience of aseptic techniques.
Significant experience in implementing environmental control programs and OOL investigations and corrections
Experience of microbiology in an aseptic facility.
Experience interfacing with regulatory inspectors with a positive outcome.
Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
Preferably have Pharmacy Compounding experience.
Experience in the interpretation and implementation of the MHRA Specials Guidance is preferable.
Ability to communicate quality operations and compliance perspective effectively to senior management.

This role represents an excellent opportunity to join a global Pharmaceutical Manufacturer, with operations on multiple continents.


Job Type: Permanent

Location: Runcorn, Cheshire

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