Warning letters, 483s, Recalls, Import Alerts, Audit observations
GLP Document Control, Study Protocols Issuance and Reconciliation, Clinical sample management
Shift production activities, Sampling, Calibration, Cleaning, Verification
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,
