Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.
Post : Executive - Sr.Executive (Quality Assurance - IT)
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/ IQ/OQ/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
Last Date : 25th April 2024
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