QCS Staffing
Sterility Assurance Lead
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Sterility Assurance Lead – Swindon, UK – Initial 6-Month Contract – Life Sciences
Would you like to support one of the largest CMO’s in the world? Well look no further as we may have the opportunity for you!
Our client is seeking a Sterility Assurance Lead to support their project located in Swindon for an initial 6 month duration.
It is a fast paced and exciting environment which is seeing a lot of internal investment. This is the chance to get involved with a global client who is going from strength to strength.
With several exciting refurbishment projects in the pipeline this is a great chance to be involved in the full project lifecycle with the opportunity to move into other projects and areas of the business.
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- Generate and maintain the contamination control strategy
- Promote understanding of and compliance to SA related regulations such as EU Annex 1 & the FDA’s aseptic processing guide.
- Implement regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements, and provide real-time coaching to aseptic staff.
- Define, oversee, and improve the EM & APS programs.
- Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with overseeing aseptic manufacturing.
Experience Required:
- Minimum Science-based degree in Chemistry, Pharmacy, or Microbiology
- Substantial experience working in a pharmaceutical Quality department on a sterile site.
- Substantial Quality Assurance experience and ‘hands-on’ knowledge of all Quality Systems required for a sterile manufacturing facility. Understanding of the principles of sterile manufacturing.
- Demonstrated ability to make sound decisions regarding the evaluation of GMP compliance, and leadership abilities in the management of QA oversight.
- Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211, and other relevant regulations.
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