- Planning and execution of CSV, SCADA, HMI, Calibration of Instrument and Login/IT Related Access System pertaining to Manufacturing facility at Udaipur site in line with the cGMP requirements of national and international regulatory authorities.
- To Perform Vendor Management Activity to assure that Vendors are Complying with CPL SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products.
Principal Task and Responsibilities: 1. Validation of computerized system as per regulatory requirement and Data integrity of computerized system.
- Prepare/Review/Revise SOPs related to computerized system validation.
- Prepare/Review/Revise master validation plan for computerized system validation.
- Prepare/Review/Approve validation deliverable related to CSV.
- Periodic review of all GxP computerized system and Monitoring User Account Management of GxP System. 6.
Monitoring Data
Backup, Archival and Restoration of GxP System. 7.
Monitoring Inventory
Management of GxP System, Information Security Policy of GxP Systems & PLC, Spreadsheet validation activity and IT SOPs. 8.
Instrument Calibration
Planner, Schedule & Calibration Certificate review, approval and assessment, review, approval of Breakdown Maintenance & Preventive Maintenance activity.
- Document controlling, issuance and retrieval.
- To participate in Internal (Self inspection) and External audits.
- To assist for any other assigned jobs from time to time.
- To conduct the self-Inspection/ Date Integrity inspection of different departments. Any other jobs assigned from time to time.