Key Responsibilities:
- Develop and validate analytical methods for drug substances and drug products
- Handle techniques like HPLC, GC, UV, IR, Dissolution, etc.
- Perform method transfer to QC/plant locations
- Prepare protocols, reports, and documentation as per regulatory guidelines
- Support stability studies and impurity profiling
- Ensure compliance with GLP, cGMP, and data integrity norms
- Troubleshoot analytical issues during development and commercial stages
- Work closely with R&D;, QA, and manufacturing teams