Successful 20+ years of Pharma and Biopharma Experience in Quality Control, leading a good numbered team..Having sound understanding on Sample/ retention sample management, Stability Management, Reference Standard management, Analytical Method Transfers, Analytical Method verification/ Validation, Analyst Qualification, Equipment/ Facility Qualification. Having strong understanding of Quality Management systems including Change and Deviation management, OOS/OOT management, Failure Investigation and Root cause analysis, CAPA and its effectiveness monitoring, Vendor management, Audits, Employee Training. Having sound experience in the setup of new Quality Control laboratories, systems and documentation along with buildup of a strong technically competent, cohesive and delivering team. Qualification of analytical instruments. Management of Pharmacopoeial compliances. Handling QM modules in SAP. Actively involved as a functional support for implementation of LIMS.