Sterility Assurance Lead

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Location: Swindon, UK
Employment Type: Full-time (40 hours/week)
Pay Rate: £50-£75 per hour
Duration: Until December 31, 2025
Start Date: ASAP
Work Schedule: Monday to Friday, 8:30 AM - 4:40 PM

Are you ready to take charge of Sterility Assurance in a dynamic environment? Join our client as a Sterility Assurance Lead and be at the forefront of ensuring the highest quality standards in the pharmaceutical industry!

As the Sterility Assurance Lead, you will drive our contamination control and sterility assurance strategies. You will work collaboratively with your team to ensure compliance with the latest regulations while fostering a culture of continuous improvement.

• Own and implement the Contamination Control Strategy and Sterility Assurance strategy for the site.
• Monitor operational activities to minimise environmental contamination and product risk.
• Collaborate with teams to manage quality events impacting sterility, including evaluating deviations and microbiology complaints.
• Maintain and update the site microbiology risk assessment and sterilisation-in-place concept.
• Write and review Standard Operating Procedures (SOPs) related to sterility assurance.
• Support the Environmental Monitoring (EM) review and action planning for continuous improvement.

• Education: Master's Degree in Microbiology.
• Experience: Minimum 5 years in microbiology within the pharmaceutical industry, with a solid grounding in GMPs and regulatory compliance (EU GMP annexe
  1).
• Skills:
  • Strong understanding of sterility assurance, process validation, and contamination control strategies.
  • Excellent interpersonal and communication skills, with the ability to make informed scientific decisions.
  • Proven ability to mentor and coach junior team members.

• Entry level

• Full-time

• Quality Assurance

• Pharmaceutical Manufacturing