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Sterility Assurance Lead

2 weeks ago

Swindon, Swindon, United Kingdom Oxford Global Resources Full time £65,000 - £85,000 per year

Sterility Assurance Lead


Swindon, UK
|
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.