AstraZeneca GmbH

Job Responsibilities Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. qualification and audit of cell supplying vendors. Perform qualification and audit of cell supplying vendors. Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. qualification and audit of cell supplying vendors Provide Quality oversight to Apheresis, Cryopreservation and infusion centers. Author and negotiate quality agreements Participate and provide support to deviations, CAPAs, OOS, change controls and product complaints involving Apheresis and Infusion centers and cell supplying vendors. Liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality related issues. Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies. Audit readiness support for regulatory inspections queries...