More than 14+ Years of experience in Process Development and Technology Transfer of US, Europe, WHO & ROW Projects from R&D to manufacturing site and site to site transfer.Handling Scaleup/Exhibit/Commercial Launch activities which includes Change controls, VSR, AVL updation, Scale up/EB Protocol/Report, Batch Records finalization. Finalization of CPP/ CQA/ CMA of oral solids and liquids formulation.Handling of Alternate Vendor Development of Active Ingredients and Excipients for cost saving in existing commercial Products.Process improvement in existing products, Post approval changes, Technical justification reports and handling of documents to DRA for submission.Performs objective technical investigations including CAPA, Risk Assessment, Deviation and manufacturing investigations related to OOS/OOT.Handled Qualification activities which includes preparation and review of documents like URS, SAT, FAT, DQ,IQ,OQ,PQ,GAP Assessment and Traceability matrix reports and coordination with different vendors. Finalization of quotations, initiation of Purchase requisition, Indent, Capex and opex requirements. Responsible for SOP preparation for critical operations and revision, Batch booking, recipe creation, Maintenance of material master in SAP system. Well aware about current software like SAP, eTMS, LIMS, SAP ARIBA, eDMS, eBMR, Trackwise etc.Handling of QMS activities, Shop floor execution and monitoring of PPQ batches and continuous process verification of launched products.Review of executed batch records, e-BMR execution and posting of TT (Transfer Ticket) in SAP .Responsible to handle internal and external regulatory audits with zero major and critical observations which includes preparation of technical documents like manufacturing process flow charts, gap assessment and preparation of internal audit response.Continuously improve manufacturing processes for better efficiency, productivity and product quality under safe working environment.Well aware of handling Glatt, Sejong, ACG, cadmach and Tapasya equiments.Finalization of Machine software as per process flow for RMG, Blender in co-ordination with vendor support to fulfill Gxp and 21 CFR requirements.Manpower management along with product execution to achieve the stipulated timelines for T0 of products.Ensure to aim to achieve zero deviations and 100% utilization of available resources (Manpower, Machines, Change Parts requirement for new products and budget).