Introduction

Vos tâches

• Global Quality Business Partner focused on the Quality Management of IT System implementation projects and for the Life Cycle 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 providers.

Votre profil

• Master’s degree in IT, Pharmaceuticals, Engineering, Life Sciences or a similar field.
• Profound knowledge of FDA- / EU-Guidelines, including computer system validation, quality risk management and data integrity.
• Long-term professional QA experience in supporting IT applications in a global GxP environment throughout the whole lifecyle of an application, preferred in a CDMO business.
• Confident handling with electronic systems, ideally to be familiar with Trackwise, Labvantage, SAP, eCTD Manager.
• Fluent communication in English.
• Excellent interpersonal and communication skills.
• Highly self-motivated with “Can do” mentality and a strong sense of ownership.
• Flexibility and willingness to travel (< 10%).

Please note that this role can be filled at any of Corden Pharma's European sites.