Line clearance at all stages of operations as per SOP/BPCR.Monitoring of Aseptic process simulation and process validation (PV)and review of protocols. Routine IPQA activities of sterile injectables on ampoule, vial and PFS lines. Sampling at different stages of manufacturing and EM monitoring. Review of BMR and cGMP records and participating in manufacturing investigation.Review and verification of documents, raw data, reports, prints, log books etc. Coordination with production, QC, Warehouse for GMP Compliance.Reporting all the deviations to Incharge- IPQA Verification of cleaning activities. Verification of EMS data, cleaning checklists, qualification of equipment, personnel, as per schedule. Coordinating with training department to meet training requirements as per company policy. Coordinating with validation department for online completion of validation and calibration activities. Maintaining and monitoring safety at all stages of activities.Successfully participated in CDSCO, USFDA, EMA, MHRA audit compliance activities.

Quality Assurance- VaccinesLine clearance at all stages of operations as per SOP/BPCR during Drug Substance (DS) manufacturing for Sputnik Vaccine. Process Validation and Submission batch handling and protocol review and preparation in accordance with Technology Transfer Documents (TTD). Involved in Aseptic process simulation and review of APS protocol. Review of PM data, alarms, excursions etc in the manufacturing. Preparation and execution of protocols, reports, records, BPCR. Review of Deviations, Change Controls related to manufacturing.Check for adherence to SOPs in all departments. To survey all departments, which contribute to production of APIs for deviations from cGMP. To review the product manufacturing records, testing records, and monitoring the release batches trend before the dispatch. Responsible for in process and API sampling.Responsible for EM plates exposure and air sampling in manufacturing facility. OOL, OOS, batch failure investigation in manufacturing. Complying the IPQA role in QMS activities. Review of detergent UV analysis, pH, conductivity reports of rinse water.

Involved in process flow of Vexi flu-4, ELISA for Covid-19 antibody test in Production and R&D Production. Responsible for giving the line clearance for Rivastigmine transdermal Patch Dispensing and Manufacturing. Management of document and archival of document cell. New SOP effective in documented procedure through TIMS. Daily logbook review with archival of logbook. Issuance, retrieve and archival of BMR, BPR, protocol, STP, GTP, Specification and all type of GMP document.