Sterility Assurance Lead - Pharmaceutical Manufacturing
Swindon (On-site)
£50-£75 per hour
Full-time | Monday to Friday | 8:30-16:40 | No shift work
Temporary contract | Immediate start available
About the Role
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.
Key Responsibilities
Lead and maintain the site's Sterility Assurance and Contamination Control Strategies.
Oversee operational surveillance activities to minimise contamination and product risk.
Manage and assess quality events, deviations, and complaints related to microbiology or sterility.
Own and update the microbiology risk assessment and Sterilization-In-Place (SIP) strategy.
Write and review SOPs related to sterility assurance and support change control evaluations.
Review Environmental Monitoring (EM) data and lead continuous improvement initiatives.
Provide technical guidance and mentorship to team members and QA staff.
Participate in meetings and cross-departmental projects to maintain compliance and timelines.
About You
Master's degree in Microbiology (or related field).
Minimum 5 years' experience in microbiology or sterility assurance within the pharmaceutical industry.
In-depth understanding of GMPs, EU GMP Annex 1, and regulatory compliance.
Strong knowledge of sterility assurance, validation, and contamination control principles.
Excellent interpersonal, communication, and problem-solving skills.
Able to work independently, manage multiple priorities, and collaborate across departments.
Fluent in English (written and spoken).
Why Join Us?
Competitive hourly rate (£50-£75)
On-site role in a well-established, modern facility in Swindon
Supportive, professional environment with opportunities to make a real impact
PPE and equipment provided
Standard working hours (no shifts or weekends)