Sterility Assurance Lead - Pharmaceuticals

Swindon (On-site)
50-75 per hour
Full-time | Monday to Friday | 8:30-16:40 | No shift work
Temporary contract | Immediate start available

We're looking for an experienced Sterility Assurance Lead (Senior QA Sterility SME) to take ownership of the site's Contamination Control and Sterility Assurance Strategy. This is a key quality leadership role within a pharmaceutical manufacturing environment, ensuring the highest standards of compliance, safety, and product integrity.
As the site's subject matter expert, you'll drive continuous improvement, collaborate with cross-functional teams, and lead sterility assurance initiatives in line with the latest EU GMP Annex 1 and regulatory expectations.

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  Lead and maintain the site's Sterility Assurance and Contamination Control Strategies.
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  Oversee operational surveillance activities to minimise contamination and product risk.
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  Manage and assess quality events, deviations, and complaints related to microbiology or sterility.
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  Own and update the microbiology risk assessment and Sterilization-In-Place (SIP) strategy.
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  Write and review SOPs related to sterility assurance and support change control evaluations.
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  Review Environmental Monitoring (EM) data and lead continuous improvement initiatives.
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  Provide technical guidance and mentorship to team members and QA staff.
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  Participate in meetings and cross-departmental projects to maintain compliance and timelines.

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  Master's degree in Microbiology (or related field).
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  Minimum 5 years' experience in microbiology or sterility assurance within the pharmaceutical industry.
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  In-depth understanding of GMPs, EU GMP Annex 1, and regulatory compliance.
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  Strong knowledge of sterility assurance, validation, and contamination control principles.
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  Excellent interpersonal, communication, and problem-solving skills.
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  Able to work independently, manage multiple priorities, and collaborate across departments.
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  Fluent in English (written and spoken).

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  Competitive hourly rate (50-75)
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  On-site role in a well-established, modern facility in Swindon
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  Supportive, professional environment with opportunities to make a real impact
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  PPE and equipment provided
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  Standard working hours (no shifts or weekends)