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    QC Manager, Pharmaceutical - London, United Kingdom - Hobson Prior

    Hobson Prior
    Hobson Prior London, United Kingdom

    4 weeks ago

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    Description
    Hobson Prior is seeking a Senior QC Manager Analytics for a permanent role based in London.

    The successful candidate will be responsible for overseeing the Quality Control department, ensuring the laboratory is always ready for inspection and that all data generated is compliant with internal and external requirements.

    This role will also involve providing line management to members of the QC analytical team, contributing to the overall group objectives and staff development.

    Ensure day-to-day management of the QC analytical department, ensuring the laboratory is inspection ready and that any data generated is valid and in compliance with applicable internal and external cGMP requirements.

    Oversee the Quality Control department to support the quality control release and stability testing of gene therapy products and associated materials.

    Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff.

    Ensure that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance's, and is undertaken in accordance with applicable procedures (e.g., Experience working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site.

    Proven track record of managing a team within a cGMP QC analytical environment.
    Degree in a relevant scientific discipline or equivalent experience.
    Understanding of GMP requirements e.g.

    legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g.

    of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10.


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