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
