Address 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.
