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Are you a Master's-educated Microbiologist ready to step into a leadership role where your expertise directly safeguards product quality and patient safety? We are seeking a highly experienced and proactive Sterility Assurance Lead (Senior QA Sterility SME) to own and drive the Contamination Control and Sterility Assurance strategy across our entire Swindon facility.
This is a critical, hands-on role for an expert with at least 5 years of proven microbiology experience in the pharmaceutical industry, possessing deep practical knowledge of GMPs, EU GMP Annex 1, and the latest regulatory compliance.
The Opportunity: Own Sterility Assurance
As our Sterility Assurance Lead, you will be the site's authority, responsible for the integrity of our sterile manufacturing environment and products.
Key Responsibilities Include:
- Strategy Ownership: Develop, implement, and maintain the site's Contamination Control Strategy and overall Sterility Assurance strategy, ensuring compliance with the most updated regulations and industry best practices.
- Risk Management: Own and maintain the site Microbiology Risk Assessment and the Sterilization-in-Place concept.
- Quality Event Management: Actively collaborate on the floor to manage quality events impacting sterility, providing expert microbiological input for deviations and complaints.
- Continuous Improvement: Support the Environmental Monitoring (EM) review and drive action plans to continuously increase the Sterility Assurance Level across all processes and systems.
- Documentation & Change: Write and/or review critical SOPs and evaluate changes with a potential impact on product quality.
What You Bring:
- Education: Master's Degree in Microbiology.
- Experience: Minimum 5 years in pharmaceutical industry microbiology, with extensive background in sterility assurance, process/cleaning validation concepts, and contamination control.
- Expert Knowledge: A deep working understanding of GMP regulations and international guidelines, especially EU GMP Annex 1.
- Leadership: Strong interpersonal and communication skills with the ability to coach and mentor junior employees and lead compliance/scientific discussions.
- Availability: Participation in on-call services, remote, based on departmental needs.
Work Details:
- Location: Swindon, UK
- Schedule: Full-time, Standard working hours (Mon-Fri) 8:30-16:40
- Environment: Requires some degree of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)
If you are ready to take full ownership of sterility assurance at a leading pharmaceutical site and drive regulatory excellence, apply today!
Interested? Please apply using the button below or call Danielle on (phone number removed) for an informal discussion.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
