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    Validation Manager - Cambridge, United Kingdom - CK Group

    CK Group
    CK Group Cambridge, United Kingdom

    1 month ago

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    Default job background
    Pharmaceutical / Bio-tech
    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.


    The Role:


    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


    Responsibilities :


    Manage a team and ensure validation master plans (VMPs), protocols and procedures are establishednTo prepare and maintain validation plans (VPs) and identifying validation requirements.nAssist in the authoring of User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes.

    nWorking with external companies and project teams to ensure activities that require specialist knowledge are completednExecuting validation protocols for equipment, facilities and utilities


    Your Background:


    Degree (or equivalent) in a Science or related disciplinenQualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies).nExperience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical.

    nSignificant experience leading validation activities within the biopharmaceutical or ATMP sectorsnUnderstanding and experience of aseptic processing and cleanroom technologiesnProven track record of establishing validation master plans (VMPs)


    Apply :
    It is essential that applicants hold entitlement to work in the UK. Please quote job reference 99463 in all correspondence

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