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.
Gland Pharma is the worlds leading player in Injectables Formulation and Manufacturing. It is also into API and Intermediates research and manufacturing. Gland Pharma is present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505b2 filings.
Post : Research Associate / Senior Research Associate
Review of Master Batch production and control record BPCR and review of Master media fill records & Review of complete Batch records before release. Preparation and review of media fill Protocols and Reports.