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    Quality Assurance Specialist Hybrid - London, United Kingdom - Northreach

    Northreach
    Northreach London, United Kingdom

    2 weeks ago

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    Description

    Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors.

    Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

    Works within established processes, guidelines and methods ensuring quality guidelines are adhered to
    Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
    Day to day responsibilities include the following elements of the PQS relating to manufacture and testing of cellular therapies including;
    Document control system, Training system, Change controls
    Quality risk management
    Participates in risk assessment and investigations as required
    Draft, review and approve Quality and GxP related documentation
    Provides advice and guidance to the Quell manufacturing and QC teams on Quality related issues
    Assists in the generation of quality metrics
    Highlights quality related matters or risks to others that could impact product quality, product release or regulatory compliance.
    Provides general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
    Promote quality culture and one of continuous improvement within team
    Min 2 years' experience or equivalent experience working in a Quality Assurance role in a GMP environment
    Experience in providing pragmatic quality advice to manufacturing and quality control functions

    Experience writing and reviewing GxP documents (including SOPs) to ensure good documentation, data integrity, GxP, quality and regulatory requirements are met.

    A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP's is required
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