• Validation of computerized system as per regulatory requirement • 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. • Monitoring User Account Management of GxP System. • Monitoring Data Backup, Archival and Restoration of GxP System. • Monitoring Inventory Management of GxP System. • Monitoring Information security Policy of GxP Systems. • Monitoring of PLC and Spreadsheet validation activity. • Monitoring activity related to IT SOPs. • 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.
