Introduction
Publication de postes au sein de l'entreprise
Département:
Lieu: Frankfurt
Global Quality Business Process Manager (m/f/d)
Frankfurt, Germany
- Frankfurt
- ASAP
- Temps plein
- Durée indéterminée
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.