CSV, IT infrastructure qualification| Agile, DMS, 21 CFR part 11, EU GMP Annexure-11, cGMP compliance, End to end implementation, risk assessment, change management, incident/ deviations, CAPA, GAMP categorization, Gap Assessments, GDP, Data integrity and ALCOA+. Involved in regulatory audits like USFDA, MHRA, WHO and ANVISA.

Upgradation of manual systems to 21 CFR compliance, CSV for SCADA/IPC/HMI/PLC of manufacturing, packing, laboratory and utility equipments. Responsible for Risk Assessment, change management, incident/ deviations, CAPA and Gap Assessments. Review and approval of CSV deliverables like URS, VP, HLRA, FDS, IQ, OQ, PQ and VSR. Responsible for compliance of cGMP, GDP, data integrity and ALCOA+. Actively participated in regulatory audits like USFDA, ANVISA, WHO and MHRA.

Upgradation of manual systems to 21 CFR compliance, CSV for SCADA/IPC/HMI/PLC of manufacturing, packing, laboratory and utility equipments. Responsible for Risk Assessment, change management, incident/ deviations, CAPA and Gap Assessments. Review and approval of CSV deliverables like URS, VP, HLRA, FDS, IQ, OQ, PQ and VSR. Responsible for compliance of cGMP, GDP, data integrity and ALCOA+. Actively participated in regulatory audits like USFDA, ANVISA, WHO and MHRA.

CSV for SCADA/IPC/HMI/PLC of manufacturing, packing, laboratory and utility equipments including isolators. Preparation and execution of test scripts like IQ, OQ and PQ. Responsible for Risk Assessment, change management, incident/ deviations, CAPA and Gap Assessments. Preparation and review of SOPs, protocols. Actively participated in the regulatory Audits like USFDA, MHRA, ANVISA etc.

Qualification and validation of Manufacturing equipments like Autoclaves, Tunnels, Vial washing machines, Filling machines, Capping machines, Lyophilizers, CIP / SIP vessels, Packing equipments like Labelling, carton, shipper packing machines. Actively participated in the qualification of Utilities like HVAC, water systems, pure steam, Compressed air and Nitrogen. Involved in the qualification of laboratory equipments like incubators, ovens, stability chambers, deep freezers, cooling chambers. Preparation/review of qualification protocols like URS, DQ, FAT, SAT, IQ, OQ, PQ and RQ for all manufacturing, packing, utility and laboratory equipmets. Preparation of SOPs. Validation schedules.