Warning letters, 483s, Recalls, Import Alerts, Audit observations
Development of cell-based assays, ELISA, flow cytometry-based assays, characterization bioassays
Handle shop floor manufacturing activities, Materials for production, Production documentation and reviewÂ
Review of TDS of Environmental monitoring, Microbiology tests, BET & Bioburden tests, Review of SOPs
Provide patent validity search and analysis, Product in-licensing evaluation for Third party Finished dosage form /
Supporting MES Specialists by providing a QA perspective. Verify compliance for activities, quality oversight of
Overseeing Quality Assurance operations for the Mammalian and Microbial manufacturing plants.
Sample Management, Analysis of Inprocess, Finished Goods, Raw Materials, Qualification, Calibration of Instruments, Method verification,
Analysis of QC Samples, Method Validation, Lab Compliance and QMS activieies of QC – OOS,
