Sterility Assurance Lead

Randstad Delivery; Swindon; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading recruitment firm is seeking a Sterility Assurance Lead to drive the Contamination Control Strategy in Swindon. This full-time role requires collaboration in managing quality events and assurance of compliance with current regulations. The ideal candidate will have strong experience in sterility assurance practices and writing SOPs. Competitive pay of £50 - £75 per hour is offered for this urgent requirement.

Qualifications

• Demonstrated experience in sterility assurance practices.
• Strong understanding of contamination control measures.
• Experience in writing SOPs related to sterility assurance.

Responsibilities

• Own and drive the Contamination Control Strategy and Sterility Assurance strategy.
• Assure the surveillance plan of operational activities.
• Collaborate on the management of quality events impacting sterility.

Skills

Contamination Control Strategy

Sterility Assurance

Microbiology Impact Evaluation

Job description

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...