Key Responsibilities :
Analytical Method Development & Validation
- Perform method development and validation for drug substances and formulations.
- Execute stability studies, assay, dissolution, and impurity profiling.
- Analyze samples using HPLC, GC, UV, FTIR, and other analytical techniques.
Documentation & Compliance
Prepare and review analytical reports, protocols, and SOPs.Ensure accurate data recording in lab notebooks and maintain GLP documentation.Comply with cGMP, GLP, ICH, and other applicable regulatory guidelines.Instrument Handling
Operate and maintain instruments like HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus, and pH meters.Ensure instrument calibration and readiness before analytical operations.Product Development Support
Support formulation and development teams through timely analysis of developmental batches.Assist in technology transfer by providing analytical support to manufacturing units.Quality & Safety
Follow all laboratory safety procedures and practices.Participate in internal audits, investigations, and OOS / OOT evaluations as required.Skills Required
Hplc, Gc, Ftir, Glp