Senior Associate Scientist
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 incidents or deviations including root ca use analysis, impact assessment, and CAPA through 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, justification documents and related raw data.16. Wide experience of new lab set up and skilled with new instrument purchase, qualification exercise and instrument Life Cycle Management (LCM).17. Exposure of USFDA, EMEA and Johnson & Johnson Regulatory Compliance Audits.18. Exhibit the knowledge of Data integrity and managing the lab compliance for audit readiness
