Strategically focused Quality professional with more than 19 years of management and leadership in developing, establishing and improving quality system, programs, policies, investigation and trending of quality data streams. Having experience in quality department in company like Ranbaxy Lab Ltd, Ind-Swift Labs Ltd,Glenmark Generics and presently in Daiichi SankyoStrong expertise in the development and implementation of sustainable and compliant GxP Quality Systems in global regulated drug environments. Collaborative facilitator and leader known for motivating cross-functional teams to high performance, and championing the overall mission of Quality. Effective in meeting strategic objectives while increasing customer service levels.Specialties: VENDOR AUDIT, analytical method development and Validation,Quality Control, instrumentation (chromatography, spectroscopy, NMR, MS-MS etc.), statistic use of laboratory software, audit trails. Skilled in analytical Knowledge of drug product and drug substance manufacturing & analytical processes, Change Management, Deviation Management, CAPA, Internal Audit Risk Management, Product Quality Review, etc.) Sound knowledge of Quality Investigation tools and techniques & Root Cause Analysis