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    Quality Assurance Manager CQA - Mumbai, India - vasitum

    vasitum
    vasitum Mumbai, India

    1 week ago

    Default job background
    Description
    This position is for Quality Assurancedepartment for a pharmaceuticalcompany.
    DesiredCandidate profile 1. Shall beM.Sc. / M. Pharm / B. Pharm2. Shall haveexposure to QMS documentation of QA andQC.3. Shall have knowledge of softwares likeeQMS LIMS eBMR eLearning Management system SAPHANA.4. Shall be well versed with EU GMPPICs GMP WHO GMP and ICH guidelines5.Ability to implement computer system validation as per EU Annex 11and 21 CFR Part11
    KeyResponsibilities
    1. ToReview/ approve QMS documents like cleaning validation processvalidation hold time study equipment qualification HVACqualification Analytical method validation Technology TransferStability Study protocols BMR BPR Annual product quality reviewSite Master file Quality manual in line with EUregulation.
    2. Handling and guiding manufacturingsites technical teams in closure of market complaints deviationschange controls and Corrective and preventiveactions.
    3. To perform gap analysis with respectto cGMP guidelines Pharmacopoeias current regulatory requirements& corporate policies/ SOPs wherever required and to complywith the requirements and endorse the same.
    4. Toensure QC instruments (e.g. Chromatographic systems) Manufacturingequipments (SCADA PLCs) are in compliance with EU Annex 11 and 21CFR Part 11.
    5. To participate in vendor auditsand audits of contract testing laboratories.
    6. Toimplement electronic documentation systems like eQMS LIMS eBMReLearning Management system SAP HANA.
    7. Review ofcompliance of regulatory audits and customeraudits.


    pharmaceuticalconsulting,pharmaceutical industry,pharmaceutical projectmanagement

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