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    Senior Quality Assurance Specialist - Stevenage, United Kingdom - Autolus Limited

    Autolus Limited
    Autolus Limited Stevenage, United Kingdom

    Found in: Talent UK C2 - 4 days ago

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    Description

    Role Summary
    The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP).

    The role will be based in Stevenage.

    Key Responsibilities

    • Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies


    • Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation and archiving


    • Preparation, checking and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance

    • Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues


    • Authoring, approval and review of GxP documentation

    • Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk
    assessments.


    • Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available


    • Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions
    • Continuous improvement


    • Process and equipment qualification and validation


    • Analytical and Quality Control assay validation


    • First point of escalation issues and communication to QPs


    • Collation and trending of Quality KPIs


    • Support Product Quality Review


    • Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity


    • Support regulatory inspections - backroom support and/or SME support


    • Line management of Junior Quality Assurance colleagues

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