Sterility Assurance Lead
đź“Ť Swindon, UK | đź•’ Full-Time | On-site |
🗓️ Start Date: ASAP | 📅 Contract until 31/12/2025
Join a top-tier global leader in the pharmaceutical sector, renowned for innovation, quality, and excellence in healthcare solutions. We are seeking a highly experienced Sterility Assurance Lead to drive contamination control and sterility assurance strategies at our Swindon site.
Key Responsibilities
* Lead the Contamination Control Strategy and Sterility Assurance Program across the site, ensuring alignment with the latest regulatory standards and industry best practices.
* Oversee surveillance of operational activities to minimize environmental contamination and product risk.
* Collaborate cross-functionally to manage quality events impacting sterility, including deviations and microbiology-related complaints.
* Own and maintain microbiology risk assessments and sterilization-in-place protocols.
* Author and review SOPs related to sterility assurance; support change evaluations affecting product quality.
* Drive continuous improvement initiatives in collaboration with site teams to enhance sterility assurance levels.
Qualifications & Skills
* Master’s Degree in Microbiology.
* Minimum 5 years of experience in microbiology within the pharmaceutical industry.
* Deep understanding of GMPs, EU GMP Annex 1, and sterility assurance principles.
* Proven expertise in contamination control, process validation, and cleaning validation.
* Strong communication and stakeholder management skills.
* Ability to mentor junior staff and lead cross-functional meetings.
* Fluent in English
Work Environment & Culture
* Standard hours: Mon–Fri, 8:30–16:40 (no shifts, overtime only if requested).
* Collaborative and fast-paced environment with a strong focus on quality and compliance.
This is a unique opportunity to make a significant impact in a high-performing team at a leading pharmaceutical company. If you're passionate about sterility assurance and ready to take the next step in your career, we’d love to hear from you.