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Quality Assurance (OPERATIONAL GMP)

Just Life Sciences are the Independent Life Sciences Recruiter based in Cardiff, and are seeking a Quality Specialist who has substantial GMP Operational experience, to take on a newly created role.

Purpose

Pharmaceutical products are manufactured under the most stringent regulatory and GMP requirements, and the job holder will be required to understand and interpret regulations of MHRA/EU/FDA.

Quality must be built into the design of the facilities and the processes contained within those facilities. The job holder must be pro-active in influencing business unit colleagues up to Director level in circumstances where conflicts arise. The GMP elements of Quality Assurance are essentially "on-plant" activities however there may be a need to discuss issues/interface with clients.

The job holder is responsible for the interpretation of cGMPs for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products.

Qualifications, Skills and Experience

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