DP CMO ManagementVial PV Batch Production

A broad understanding of QMS (change control, deviation, CAPA, raw material management, complaints, etc)Supplier Qualification (raw material and service supplier - DS CMO, L&P CMO, Contract Testing Lab, etc)Supplier audits (on-site and virtual) Supplier Management (Supplier Corrective Action Request)Managing client audits, regulatory inspections (MFDS, EMA, US FDA, COFERIS, etc) and observation response writingIMPD / MAA / BLA reviewQP Declaration Raw material… Show more A broad understanding of QMS (change control, deviation, CAPA, raw material management, complaints, etc)Supplier Qualification (raw material and service supplier - DS CMO, L&P CMO, Contract Testing Lab, etc)Supplier audits (on-site and virtual) Supplier Management (Supplier Corrective Action Request)Managing client audits, regulatory inspections (MFDS, EMA, US FDA, COFERIS, etc) and observation response writingIMPD / MAA / BLA reviewQP Declaration Raw material management TSE/BSE risk evaluation, nitrosamine risk evaluationSOP writing R&D - cell cultureCell line selectionMedia selectionMedia optimizationCell culture process development Flask cell culture 3L and 10L bioreactor cell culture Show less