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

    CK GROUP
    CK GROUP Cambridge, Cambridgeshire, United Kingdom

    2 weeks ago

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    Description
    CK Group are recruiting for a


    Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.

    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 established
    To prepare and maintain validation plans (VPs) and identifying validation requirements.
    Assist in the authoring of User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes.
    Working with external companies and project teams to ensure activities that require specialist knowledge are completed
    Executing validation protocols for equipment, facilities and utilities


    Your Background:
    Degree (or equivalent) in a Science or related discipline
    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.

    Significant experience leading validation activities within the biopharmaceutical or ATMP sectors
    Understanding and experience of aseptic processing and cleanroom technologies
    Proven 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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