Warning letters, 483s, Recalls, Import Alerts, Audit observations
Supporting MES Specialists by providing a QA perspective. Verify compliance for activities, quality oversight of
Testing, inspection, and data analysis, Physicochemical, Biochemical assays and analysis for batch release, stability studies
Role in Corporate Quality Assurance of Syngene. Monitor, Review Qualification and Validation activities, documents, train
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,
Technology transfer of Biotech processes from R&D to Production, Process monitoring, Development of technical documents,
Analysis of QC Samples, Method Validation, Lab Compliance and QMS activieies of QC – OOS,
