Sterility Assurance Lead
Location: Swindon, UK
Employment Type: Full-time (40 hours/week)
Pay Rate: £50-£75 per hour (Inside IR35)
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!
Your Role:
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.
Key Responsibilities:
* 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.
What We're Looking For:
* 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.