Apheresis Operations InvestigatorBARCELONA (BARCELONA)Empresa: NovartisDescripció: The Apheresis Operations Investigator leads is responsible for ensuring that issues related to cellular material received in Europe are appropriately evaluated, investigated, and have required feedback and follow-up with the sites providing the cells (i.e. apheresis sites). The position is responsible to manage simulated processing/mock shipments, and maintain KPI metrics on deviations to the site and network level. Apheresis Operations Investigator will interface and collaborate closely with the Apheresis Operations Tissue Experts who interface directly with the hospital customers acting as cellular material suppliers.? Ensure that incoming cellular material have deviations assigned as coordinated with internal receiving and QA groups. ? Receive ownership of deviations, ensuring that immediate assessment and product impact assessment are completed to avoid manufacturing start delay in cases where there is no impact, ensuring that ensuring that clinical QA is appropriately involved when clinical Protocol Deviation may also have occurred. ? Lead Investigation to identity the root cause of Deviations, through direct investigation, and coordination of investigation actions with field force apheresis operations team working with hospital customer/suppliers, clinical operations, and other cross-functional organizations as needed. ? Ensure that appropriate CAPA are determined, accepted by QA, and assigned to the appropriate function. ? Working with Apheresis Operations Tissue Experts and project management, ensure that needed ?mock shipments? for sites are scheduled, and have healthy donor cellular material coordinated and scheduled as required. ? Ensure that mock shipment material is received per SOP, and ensure that the ?feedback form? assessment has been completed. ? Evaluate mock shipment for success, and recommend appropriate feedback for the sites, coordinating with site-assigned field Apheresis Operations Tissue Experts. ? Support implementation and maintenancRelació laboral: LABORAL INDIFERENTNombre Hores: 0Salari mensual des de: 0Salari mensual fins a: 006/03/2018

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