Opening for Quality Assurance-IT at Sun Pharma

Swapnil
0

Quality Assurance-IT

*Position

: Executive - Sr. Executive

  • Experience : 6-8 Years
  • Qualification: B.Pharma / M.Sc / B.E. (Electronic and Communication)

Job Profile

  • Preparation and review of CSV documents of software based systems
  • (manufacturing, Enterprise and Lab system etc.)
  • Preparation & review of URS/Vendor assessment/ Risk assessment/ 1Q/0Q/PQ.
  • Preparation & review of Configuration specification, design specification, RTM, VSR.
  • Review of QMS related activities (Change control, Unplanned/Planned deviations, Investigations, CAPA) pertaining to Computerized systems.
  • Preparation and Review of computerized system perspective SOPs.
  • Responsible to ensure GxP Computerized compliance with the current regulatory standards. (Firmware based device, Process Control Systems- HMI/IPC, PLC/SCADA, Spreadsheet etc.).
  • Ensure the availability of inventory of computerized systems and infrastructure, and ensure its compliance status.
  • Ensure the periodic activities as per the quality procedures are performed in a timely manner.
  • To support site cross functions to resolve issues related to computerized systems.
  • Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.
    Job Location: Sun Pharmaceuticals Industries LTD. HALOL Plant (Gujarat)
    Interested candidates can share CVs on disha.chauhan@sunpharma.com

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