Sterility Assurance Lead

Description

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

PRESENT

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Ad ID: 5417048001