Umesh Pathak

Background

About Umesh Pathak

Focused & Competent management professional with 18 years of experience in New Product development (as, Solid Orals, Liquids, Suspensions, Nasal Sprays etc) from project initiation, development, regulatory queries and launch to market. People manager & leading various functions from analytical R&D, method development, method validation, method transfer to local and global sites. Strong support to QC for USFDA audit preparation. Quality professional & supported QA in various aspects as implementation of GQP/QMS, Quality agreements, CAPA’s, Change Controls, Audit exposure (GQA/CQA/USFDA) and acted as SME/lead for method transfer & equipment qualification. Handled auditors’ queries without any observations. Site Lead for Computer System Validation (CSV). Proven in setting up of new facility, equipment’s & software from initiation to GmP release of lab e.g Spray Characterization lab & also acted as an lead for Spray characterization product development. Strong adherence to compliance & Lab governance. Accomplished with proven research professional Pharmacy background. Focused, Agile and Fast Learner.