A Pharma professional with over 35 year experience in the Pharmaceutical Industry of high credentials in the area of Quality and Regulatory Affairs function. Expertise in driving Manufacturing Operations through Quality by Design from the project design / implementation stage to routine commercial manufacturing operations for Regulated markets and for Rest of the World. Pioneered in leading large teams to meet Regulatory requirements & manage Quality Operations in a highly regulated environment of US, EU, S.Africa, Latam besides the Rest of the World. Possesses expertise to design manufacturing facilities to produce Active Pharmaceutical Ingredients (APIs), and Drug products meeting high Quality standards and Compliance requirements of various markets. Very proficient in API and Drug product manufacturing processes which helps in “root cause analysis” and implementation of QbD on shop floor, in addition to meeting compliance requirements in day to day operations. Also has the ability to closely work with Business Development group to translate new Business Development opportunities into viable commercial value to meet Company’s core business objectives. Very well experienced in developing proper understanding in all areas of Pharmaceutical Manufacturing - APIs, Solid dosages, Injectable dosage forms and other complex pharmaceutical products. Believes in team building and people development to enhance skill level, develop multi skill sets, create decision making environment and assume accountability. Also well versed in building competitive and committed teams to meet Company’s business objectives to achieve high levels of performance, motivate subordinates for improved performance on a continuous basis.Strongly believes in transparency in all walks of life, including in professional working to get best results and build strong foundation for the Organisation.