A focused & technical savvy professional with 22+ years of rich experience in API manufacturing, in which last 3 years in HPAI manufacturing, Hands on experience of Operational excellence, Cost reduction, Quality Management, Process Improvement and technology Transfer.Excellent cGMP knowledge, faced all regulatory audits such as US FDA, PMDA, EDQM, KFDA, COFEPRIS, CDSCO, WHO.Thorough practitioner of continuous improvement approach, undertaken projects to calculate base line OEE of capacity bottleneck equipment and then performed loss tree analysis to identify various losses to draw the action plan to reduce them. Comprehensive technical knowledge of product, unit operations and manufacturing process, operational safety, process hazard analysis & HAZOP Studies A keen performer with exposure in managing R&D/scale up activities, manufacturing and technology transfer activities involving resource planning, design & development, team building, communication and coordination with service & internal departmentsProven expertise in managing investigations, deviations, CAPA and change control management as well as dealing with customer and regulatory auditsHardworking leader with excellent communication, technical and capability building skills