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- In this role your responsibilities will include:Perform routine testing techniques such as the following, with a high degree of reliability, efficiency and accuracy:HPLC/UPLC chromatography-based methodsCapillary electrophoresis based methodsSpectrophotometry based methodsProcess related impurities testing based on ELISA, ddPCROD and TOC Test.Compendials methodsDeliver data treatment and analytical reports of high quality.Contribute to the writing of SOPsIn this role your responsibilities will include:Perform routine testing techniques such as the following, with a high degree of reliability, efficiency and accuracy:HPLC/UPLC chromatography-based methodsCapillary electrophoresis based methodsSpectrophotometry based methodsProcess related impurities testing based on ELISA, ddPCROD and TOC Test.Compendials methodsDeliver data treatment and analytical reports of high quality.Contribute to the writing of SOPs
- Key Accountabilities Coordinate and ensure the preparation and maintenance of documentation (e.g., SOP/WI, protocols/reports) within your area of expertise.Support the scaling-up from 200L to 2000L of suitable purification processes for manufacturing operations (Pre-clinical and Clinical).Assist your manager in coordinating activities within your scope of responsibility.Produce large-scale NBEs for pre-clinical or clinicalKey Accountabilities Coordinate and ensure the preparation and maintenance of documentation (e.g., SOP/WI, protocols/reports) within your area of expertise.Support the scaling-up from 200L to 2000L of suitable purification processes for manufacturing operations (Pre-clinical and Clinical).Assist your manager in coordinating activities within your scope of responsibility.Produce large-scale NBEs for pre-clinical or clinical
- Objectif du poste :Respecter les indicateurs qualité afin de libérer les lot à temps pour nos patients et nos clients. Coordonner le processus de liberation des produits fabriqués sur le site avec les différents départements Engineering & Maintenance, Assurance Qualité, Production, Supply, Warehouse et Controle Qualité.Participer activement aux ameliorations de process de liberation et notamment à sa digitalisationÊtre le référent QAObjectif du poste :Respecter les indicateurs qualité afin de libérer les lot à temps pour nos patients et nos clients. Coordonner le processus de liberation des produits fabriqués sur le site avec les différents départements Engineering & Maintenance, Assurance Qualité, Production, Supply, Warehouse et Controle Qualité.Participer activement aux ameliorations de process de liberation et notamment à sa digitalisationÊtre le référent QA
