Executive- QA of QC - Sahibzada Ajit Singh Nagar, India - SUN PHARMA

    SUN PHARMA
    SUN PHARMA Sahibzada Ajit Singh Nagar, India

    2 weeks ago

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    Description
  • Review of Raw Material/Packaging Material /Stability/ Microbiology/ Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents.


    • • Review and approval of Exhibit Stability Protocols.


    • Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol.


    • Approval of additional testing requests (if required).


    • Review and approval of ln-Vitro/CU and dissolution sheets.


    • Review and approval of Analytical Method Transfer documents.


    • Participation in handling OOS, OOT, Investigation and deviations related to

    Quality Control.


    • Review and approval of weekly and monthly software verification reports of

    Empower3.


    • Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator.


    • Review of lab instruments calibration/preventive maintenance data.


    • Review of Stability test results in NOVATEK software.


    • Approval of Certificate of Analysis.


    • Review and submission of analytical data to site regulatory affairs.


    • To provide the response of regulatory affairs and Office of data reliability queries.


    • Review and approval of change control request, specification, standard test procedure and SOP in Documentum Compliance Manager System.