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    Quality Assurance Associate - United Kingdom - Achilles Therapeutics Limited

    Achilles Therapeutics Limited
    Achilles Therapeutics Limited United Kingdom

    2 weeks ago

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    Description
    We are breaking new ground with our science creating products that have never been made.

    The role is based in Stevenage which is a key facility in manufacturing of the company's personalised T cell therapy products for use across Achilles clinical trial programmes.

    This role will play a key part in supporting and maintaining the quality systems and processes to maintain operations for GMP production and Quality Control testing.

    Additionally, ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained for ATIMPs (Advanced Therapy investigational Medicinal Product).

    Support operational QA duties to ensure GxP compliance and other regulatory requirements relating to the manufacturing and conduct of clinical trials
    QA review and approval of procedures, master batch records, and any other relevant cGMP documentation
    Review standard operating procedures (SOPs) to ensure compliance with GMP and other relevant regulatory requirements
    Providing manufacturing and quality control functions with QA support
    Work with teams across the business and externally to investigate quality issues
    Support complaints management process and where appropriate respond to complaint investigations
    Support the hosting customer audits and regulatory inspections
    Support of provision of In-house training activities
    Provide support and data for Achilles quality management reviews

    Demonstratable work experience in a QA role with a Biotech/Biologics/ATMP GMP Environment, ideally on MIA /MIA IMP Licensed Site.

    Baseline technical knowledge of aseptic manufacturing processes, sterility assurance and laboratory techniques
    Knowledge about regulatory requirements for ATIMPs

    We will consider individuals with a QC background who have experience of QA activities and can demonstrate competencies to pick up technical knowledge quickly.

    This is a permanent role, offering a competitive benefits package
    At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork.

    Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.

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