Sterility Assurance Manager

Not specified
16 Jul 2021
15 Aug 2021
Chris Carey
Contract Type
Full Time
We are currently looking for a Sterility Assurance Manager to join a leading Life Science company based in the Cambridgeshire area. As the Sterility Assurance Manager you will be responsible for all activities relating to site based Sterility.


Your duties as the Sterility Assurance Manager will be varied however the key duties and responsibilities are as follows:

1. You will lead the implementation and maintenance of all SA processes and activities on site. As the Sterility Assurance Manager, you will be accountable for the sterility Assurance and will promote and define systems.

2. You will promote understanding and compliance of SA regulations, such as Eudralex volume 4 Annex 1 and FDA aseptic processing guidelines.

3. As the Sterility Assurance Manager, you will define and co-ordinate the Environment Monitoring Programme for the site. You will review any major/critical deviations and change controls that have an impact on SA.

4. You will ensure that suitable aseptic training / oversight programmes are in place and effective. The programmes will cover all SA activities and will be driven by you, ensuring staff compliance.


To be successful in your application to this exciting opportunity as the Sterility Assurance Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a Microbiology

2. Proven industry experience in a GMP compliant, Aseptic Manufacturing Environment.

3. A working knowledge and practical experience with Lean manufacturing tools is desirable.

Key Words: Sterile | Aseptic | Clean room | Sterility Assurance | Quality Assurance | Quality Systems | QMS | Lean | Manufacturing | Compliance | MHRA | FDA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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