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    Quality Assurance Supervisor - Indore, India - ACG World

    ACG World
    Default job background
    Pharmaceutical / Bio-tech
    Description

    Job Objective:
    To assure Quality of products
    To ensure QMS compliance as per regulatory requirements / Audit findings
    Ontime BMR release with 100% compliance


    Primary responsibilities:
    Strategic and planning
    Functional

    Core:
    -review of production schedule and their compliance to the specific requirements in the manufacturing of products.
    correct and timely issuance of batch documents.
    the completed batch documents and ensure compliance to the manufacturing process before the batch is released.
    timely review and release of batch manufacturing record as per GDP.
    traceability and reconciliation of All documents and review the same for non-compliance.
    proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval.
    of documents after its expiry period with proper record.
    all the Quality Assurance documents are filled completely.
    ensure effective implementation of DMS system in all departments.
    to QA Manager during the internal and external audits.
    to QA manager by carry out self-inspection / CTQ audits
    with the Engineering Team / Calibration team with compliance with GEFU
    of DMS system.
    of QMS system.

    Internal process
    to Regulatory Compliance,
    to GMP Audit/Process Audit,
    review and Batch Release to meet regulatory requirements,
    c-GMP compliance during the entire manufacturing process.

    People development
    Management associate on Good Documentation Practices (GDP)
    Plant associates on Good Documentation Practices (GDP)
    on compliance to Data Integrity.
    Training on the requirement of Online documentation.


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