Address This role entails the responsibility of conducting comprehensive review of Extractable and Leachable studies for Endo India, contributing to our commitment to ensuring product safety and compliance with global regulatory standards
Job Description :
- Review of analytical method development, method validation and stability testing for E&L studies for Endo/Par products.
- Sound knowledge of Extractable & Leachable studies and relevant guidelines.
- Good hands-on experience in review of calibration & qualification of Analytical instruments like LC-MS/MS, LC-MS, GC-MS, GC-MS- Head Space, HPLC, ICP-MS, IR, UV, Ion chromatography, GC-FID, GC-ECD etc.
- Good technical knowledge of finished product/stability/Raw material samples and execution of analytical method validation/verification
- Investigation of incident, deviation, OOS, and OOT during analysis to group leader.
- To train the team for E&L study
Education & Experience
- M.Sc. Chemistry with 10-12 years of related experience.
Good hands-on &experience in 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
