Deepak Girnar

Background

About Deepak Girnar

Result oriented Pharmaceutical Quality professional with 22 plus years of experience acquired through multiple roles in Quality Assurance, Quality Control & Analytical Development; in highly regulated environments for high volume/value solid oral dosage forms and products Demonstrated ability to build complete end – to – end Quality systems of regulated manufacturing sites in support of Inspection management, Laboratory QMS, Stability Management and Investigational processes. Knowledge of QbD, Risk Management, Continual Improvement, Contract manufacturing quality oversight and Regulatory submission requirements. Demonstrated leadership capabilities to drive & deliver results in both short-term & long-term with a focus on Quality, Performance, Innovation and Problem Solving. Participated as SME in successful regulatory inspections of USFDA, MHRA, MCC, TGA, ANVISA, EU countries and demonstrated continued compliance to CFRs, cGMPs, cGLPs, ICH, EMEA, WHO guidelines and practices etc.