IPQA Activities, Overall Batch process, Line clearance for product/Batch, Production. Dispensing Activities, Mfg facility Shop floor activities, Monitoring in process & Critical process parameters. PV, CV, shipment validation, Calibrations, Documentation control, SOP's & BMR, BDR, BPR, COA, Protocol, Reports Review & Compliance, QRM, QRA, APQR, VMP, SME preparation & Review as per GXP's. Handled external CMO projects as required. Experienced in Rec. Insulin Aspart, Rec. Glargine, Biphasic Aspart, Rec. filgrastim, Rec. Streptokinase Injection, Rec. Liraglutide(insulin), Biosimilars mAbs and Biopharmaceuticals. Validation/Qualification Executions for DS, DP facilities, (AHU) HVAC clean rooms, Equipment (DQ, IQ, OQ, PQ, RQ). PVP project validation plan, preparation and review of Validation SOP, protocol, Reports for Qualification of Equipment & instruments as per ICH, ISO, WHO, EU, Schedule M guidelines. Execution of AVQP as per schedule. Commissioning and Quality Validations, Operations. Classified areas validation operations handled (Sterile and Non - sterile).Worked in green field project for Sputnik Vaccine Production facility. Experienced in Water samples, Raw Materials, Packing materials, In process, Finished goods, Stability products, External samples & Intermediates SPEC, STP, Test Data sheet, COA, MSDS Review, approval and compliance. Analytical part of Standards, buffers, reagents, solutions document review and approval as per GXP's. Also being part of QMS handling like Events (deviation, incident), Change control, CAPA, OOS, OOT and others. Flexible with work, researcher of biotechnology field, Support with Quality, Product Management & development and deliverables to the customer required.