Sterility Assurance Lead

Sterility Assurance Lead / Swindon / 58,000 - 65,000 per annum (pro-rata)

We are delighted to be recruiting on behalf of Thermo Fisher Scientific, a global leader in scientific innovation, a Sterility Assurance Lead to oversee and drive site-wide sterility and contamination control strategies. This is a key role within the quality assurance function, focused on ensuring compliance with current regulations and best practices in microbiology and GMP.

Key Responsibilities:

• Lead the development and implementation of the site's Contamination Control Strategy and Sterility Assurance Strategy.
• Ensure operational activities are conducted in line with procedures to minimise contamination and product risk.
• Support investigations into quality events, deviations, and complaints with microbiological impact.
• Maintain the site microbiology risk assessment and Sterilisation-in-Place strategy.
• Write and review SOPs related to sterility assurance.
• Contribute to environmental monitoring reviews and continuous improvement initiatives.

Requirements:

• Master's Degree in Microbiology.
• Minimum 5 years of experience in microbiology within the pharmaceutical industry.
• Strong knowledge of GMPs and regulatory compliance, particularly EU GMP Annex 1.
• Expertise in sterility assurance, validation, and contamination control.
• Strong communication and decision-making skills.
• Ability to mentor junior staff and lead meetings related to QA activities.
• Fluency in English.

Work Environment:

• Fully onsite role requiring use of PPE (e.g., safety glasses, gowning, gloves, lab coat, ear plugs).
• Occasional on-call or remote support may be required.

6 month temporary contract with potential for extension
Swindon

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