This position will be required to support the review of qualification and Analytical data of Extractable & Leachable Projects. Sound knowledge of Extractable & Leachable Projects. Good hands-on experience, calibration & maintenance of Analytical instruments like LC-MS/MS, LC-MS, GC-MS, GC-MS- Head Space, HPLC, ICPMS, IR, UV, Ion chromatography, GC-FID, GC-ECD etc. Good technical knowledge of data review for finished product/stability/Raw material samples and execution of analytical method validation/verification study, instrument qualifications and calibrations. Responsible for Analytical data review of Extractable & Leachable projects. Having knowledge of quality management system (Change control, CAPA, Incidents, OOS, OOT) Coordination with Endo/PAR sites for method validation/ verification work. Support to upkeep facility for ATR for Regulatory Inspection. Preparation and Review of SOP, laboratory documents like method validation/ verification protocols & reports, SOP's, Standard Test Procedure & Specification, Education & Experience M.Sc. Chemistry/M. Pharm with 8-10 years of related experience. M.Sc. Chemistry/M. Pharm with 8-10 years of related experience.