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.