Sterility Assurance Lead - Pharmaceuticals

Manpower UK Ltd; England; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading recruitment agency is looking for a Sterility Assurance Lead to oversee contamination control and sterility assurance in a pharmaceutical manufacturing environment in Swindon. The role offers a competitive hourly rate between £50 and £75 with no shift work in a well-established facility. Candidates should have a Master's degree in Microbiology and at least 5 years of relevant experience.

Benefits

Competitive hourly rate (£50-£75)

On-site role in a modern facility

PPE and equipment provided

Standard working hours (no shifts or weekends)

Qualifications

• 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.
• Able to work independently and manage multiple priorities.

Responsibilities

• Lead and maintain the site's Sterility Assurance and Contamination Control Strategies.
• Oversee operational surveillance activities to minimise contamination and product risk.
• Write and review SOPs related to sterility assurance.

Skills

Microbiology expertise

Sterility assurance knowledge

Regulatory compliance understanding

Interpersonal skills

Problem-solving skills

Education

Master's degree in Microbiology or related field

Job description

Overview

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)