Sameer Gogate Email & Phone Number

A detail oriented, technically sound and Solution driven Scientist with total 21 years of work experience in Analytical R&D with Method Development, Method Validation, Quality and Compliance and project management skills for wide range of drug substance and drug products applicable to generic pharmaceutical industry.Experience:1. Analytical Method development and Method Validation2. Managing, planning and training the staff of analytical scientists in the method validation team.3. Planning and execution for the activities in terms of technology transfer from research unit to quality control unit.4. Preparation of Standard Test Procedure (STP) of the stability indicating method.5. Compilation and Review of Development Report (PDR).6. Investigated, documented, evaluated and solved Out of Specification (OOS) results. 7. Managed activities at both internal and external testing laboratories (CROs)8. Leading investigations into quality records including RCA, impact assessment, and CAPA in Trackwise software.9. Experience on Change management and commitment records through Trackwise.10. Responsible for maintaining cGMP, GDP practices integrated with ALCOA+++ principles in analytical laboratory.11. Responded timely to regulatory queries pertaining to regulated markets (US, EU and ANVISA)12. Gap assessment of Legacy methods with latest ICH/other regulatory requirements and guidelines.13. Worked for remediation projects for China, Korea, Japan, Mexico markets.14. Actively worked on launch and grow projects for business continuity of API and DP.15. Review and approval of analytical documents like methods, protocols, reports, and related raw data.16. Experience in new lab set up.17.