Software Validation Manager | Software Validation Manager (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
As a Software Validation Manager, you will lead an international project team focused on validating computer-aided systems within pharmaceutical development. Your core responsibility will be to ensure the lean implementation and continuous improvement of CSV&C standards in the NCE department. This involves overseeing the planning, configuration, installation, and testing of systems, strictly adhering to GxP and security requirements. You will manage validation activities for complex international applications, develop new solutions, and optimize existing ones. Collaboration with global functions to create and maintain lifecycle documentation, along with developing and organizing training for system users, are also key aspects of this role. The ideal candidate will possess a relevant Master's degree or vocational training with significant professional experience, strong project management and leadership skills, and expertise in GxP, 21 CFR Part 11, and ISPE GAMP 5.
Required Skills
Education
Master's degree (e.g., MBA, MSc) in a scientific-technical field or completed technical/scientific vocational training
Experience
- Professional experience with validation requirements for computer-aided systems in a regulated GxP environment
- Leadership experience
- Experience in international and interdisciplinary collaboration
Languages
Additional
- This position is initially limited to 18 months, with an option for extension. It offers a hybrid work model, allowing 1-2 days per week or as needed from home/remotely.
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