|1. Development of analytical methods such as Assay, Related Substances, Dissolution for new formulations for solid orals formulations.|
2. Identification of unknown impurities in stability samples using LCMS/MSMS
3. Responsible for resolving issues occur during routine analysis and stability studies.
4. Generation, isolation and charactisation of unknown impurities crossing identification threshold using LCMS.
5. Complete analysis of generic drug products targeted for US,UK market.
6. Trouble shooting in method development.
7. Calibration of analytical Instruments i.e. LCMS, HPLC, UPLC.
8. Preparation of method transfer sheets and standard test procedures.
9. Ensuring regulatory compliance by maintaining of appropriate requisite documentation/record