Warning letters, 483s, Recalls, Import Alerts, Audit observations
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,
Scale up and Tech Transfer of Cell culture processes, Optimisation of cell culture processes
Operation of bioreactors, chromatography system, shift operations, fermentation operations
