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    Quality Assurance Manager - Delhi, India - Molbio Diagnostics

    Molbio Diagnostics
    Molbio Diagnostics Delhi, India

    2 weeks ago

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    Description

    Job Description To ensure strict compliance of the Quality Management System (QMS) to current requirements of national, international standards and regulations.

    Support Quality Head in QMS and its effective implementation Through knowledge on ISO 13485:2016, ISO 14971:2019, Medical device rule 2017 and IVDR Administration of quality assurance function (documents control, issuance, retrieval and record) Ensure implementation of GMP & GDP To develop, implement and approve Quality Assurance procedures and policies.

    To effectively monitor and ensure proper functioning of quality tools such as Deviation, Change control, Incident, etc.

    To monitor activities of in process quality assurance and Lab quality assurance To prepare and review APQR (Annual Product Quality Review) Ensure customer complaints are effectively handled as per SOP.

    Coordinate Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions (CAPA) Check & review SOP's, VMP, SMF,Quality Manual, QMS documents & addition or deletion ofdocuments as per requirements Conduct internal training programs for all the departments on QMS, GMP and GDP Team handling and team Training
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