Sterility Assurance Lead (Senior QA Subject Matter Expert)
Location : Swindon Area, UK (On-Site)
Job Type : Full-time Contract
Duration : Approximately 6 Weeks (Urgent Requirement until December 31, 2025 - potential for extension)
Shift Pattern Standard (Mon-Fri)
Hours per Week : 40 hours (8 : 30 - 16 : 40)
Compensation : £50 - £75 per Hour
Responsibilities
* Own and drive the Contamination Control Strategy and Sterility Assurance strategy for the site in compliance to the most updated regulations, using good practices and continuous changes.
* Assure the surveillance plan of operational activities to be carried out in respect to the current procedures, giving support so that such interventions are performed to reduce the environmental contamination and the product risk to a minimum.
* Collaborate on the floor, within the team, the management of the quality events with an impact on sterility, supporting the evaluations on deviations and complaints with microbiology impact.
* Owns and maintains the site microbiology risk assessment and Sterilization-in-place concept.
* Responsible for writing and / or review of SOPs related to sterility assurance. Actively participate in the evaluation of changes which may have impact on the quality of the products.
* Support the EM review / evaluation including the relevant action plan requested in the light of the site continuous improvement plan, in col...
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