Planning and performance of Validation, Verification of analytical methods as per the relevant procedures, protocols. Experience in Handling of GC, HPLC, IC, UV instruments with Lab solutions, Empower, Chromelon, Magic net software and experience on LIMS.
Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review.
Analytical method development, stability samples analysis and impurities identification by using instruments like HPLC, GC, LC-MS, and other analytical techniques.
B.Sc./ B. Pharmacy /M.Sc. M. Pharmacy; Preparation and review of Standard operating procedures Retrieval of BPCRs in case of batch cancellation, planning changes. Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA.
Bacterial Endotoxin testing for routine samples, and regular water testing. Analytical method validations related to the BET, MLT, and Bioburden testing. Plate reading for different microbiological analysis. Daily Observations of the sterility test canisters, tubes.