Warning letters, 483s, Recalls, Import Alerts, Audit observations
QA activities – QMS documentation, Change Controls, Investigations and CAPA, Risk Assessment,
Development of cell-based assays, ELISA, flow cytometry-based assays, characterization bioassays
Handle shop floor manufacturing activities, Materials for production, Production documentation and review
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 /
Manage research and development quality assurance division, Responsible for Quality Systems of Development Services and
