Vikas Kumar Srivastava

Experience

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  Gracure Pharmaceuticals Ltd.

  Sept 2011 - May 2015

  QA Executive

   Preparation of Process Validation Protocol & Validation Report. Preparation, issue and review of SOPs, BMR & BPR. To review the Master Batch Records as BMR, BPR. To prepare and review of Annual Product Quality Review and trending of data as applicable. Review of executed batch documents like BMR, BPR, Analytical records and related documents for batch release Preparation of daily, weekly, monthly and quarterly reports.  Calibration verification of instruments and equipment. Verification of all in process activity of raw material store. Verification of equipment log book, environment log book, pressure differential log book, balance calibration/verification log book. Self-inspection /Audit of all section. To assist in handling of documentation control activities like issuance, archival, retrieval, storage and destruction. Perform overall QA related activity from dispensing to dispatch. Show less

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  Asihwarya Lifesciences

  May 2015 - Dec 2017

  Sr. Executive QA

   To prepare and review SOPs. Handling of Change control, Deviation, NCR and Market Complaint.  To assist in handling of documentation control activities like issuance, archival, retrieval, storage and destruction. Preparation of Process Validation Protocol & Validation Report, MFR, BMR and BPR. Ensuring that internal and external audits are properly carried out. Preparing/reviewing the internal audit schedules and checklists. Making sure that the quality related complaints are investigated and resolved. Checking and approving the BPCRs after completion. Preparation of Site Master File and Quality Manual. Checking and Inspection Related Activities. Checking the records for the proper maintenance of environment, safety and health of the working personnel. Inspection of production operation periodically and check on the implementation of Standard Operating Procedures (SOP) during the Production operation. Giving training to the personnel and evaluating the skills. Vendor and Supplier Qualification. Preparation of audit compliance report. Review of QC related document like STP, SPEC. AMV and QC report Show less

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  Acme Generics

  Dec 2017 - Apr 2021

  QA Executive

   Handling of Change control, Deviation, CAPA, Incident and Market Complaint through EQMS. Preparation of Process Validation Protocol & Validation Report, MFR, BMR and BPR. Preparation of Site Master File and Quality Manual. Preparing/reviewing the internal audit schedules and checklists. Preparation of audit compliance report.

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  Galpha Laboratories Limited

  Apr 2021 - now

  Quality Assurance