Validation Manager - Cambridge, Cambridgeshire, United Kingdom - CK GROUP

    CK GROUP
    CK GROUP Cambridge, Cambridgeshire, United Kingdom

    4 weeks ago

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    Description

    CK Group are recruiting for a Validation Manager on behalf of a growing Cell Therapy CDMO to be based at their site in Cambridge on a permanent basis.


    Reporting to the Head of Quality, you will be responsible for leading the Validation function by building the team and developing its capabilities.

    This will include ensuring activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed, in accordance with GMP requirements

    Working with external companies and project teams to ensure activities that require specialist knowledge are completed


    • Executing validation protocols for equipment, facilities and utilities
    Qualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies).


    • Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical.
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