Global Quality Business Process Manager (m/f/d)

Global Quality Business Partner focused on the Quality Management of IT System implementation projects and for the Lifecycle Management of Corporate GxP IT Applications. Subject-Matter Expert within the CordenPharma network regarding compliance with 21CFR Part11, GMP Annex 11 and GAMP5. Development of Design Requirements followed by Validation and Testing strategies in a GxP environment for new Electronic Business solutions. Evolvement and continuous optimization of the Global Validation and Lifecycle approach and its presentation to regulatory authorities and external / internal customers during inspections and audits. Supervision of cross-functional teams within the CordenPharma network during execution of new and ongoing Validation and Qualification activities for Computerized Systems. Close collaboration with CordenPharma Site Quality and IT teams for locally implemented electronic systems and support cost-efficient solutions. Review and implementation of IT quality-related processes, standards and systems. Execution of internal and external audits and responsibility for supplier management of IT service

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