Software Validation Manager | Software Validation Manager (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role is for a Software Validation Manager to lead an international project team focused on validating computer-aided systems within pharmaceutical development. The successful candidate will ensure the lean implementation and continuous improvement of Computerized System Validation & Compliance (CSV&C) standards, specifically within the New Chemical Entities (NCE) department. Key responsibilities include planning, configuring, installing, and testing systems while adhering to GxP and security requirements. This position requires managing validation activities for complex international and interdisciplinary applications, developing new solutions, and optimizing existing ones. Collaboration with global functions on lifecycle documentation and organizing user training for validated systems are also crucial. This is a hybrid position, offering flexibility with home office work, initially for 18 months with a potential for extension.
Required Skills
Education
Master's degree (e.g., MBA, MSc) in a scientific-technical field or completed technical/scientific vocational training with several years of professional experience
Experience
- Professional experience with validation requirements for computer-aided systems in a regulated GxP environment
- Professional experience with 21 CFR Part 11 and ISPE GAMP 5
- Leadership experience
- Professional experience in project management
Languages
Additional
- This is a fixed-term position for 18 months, with an option for extension. Hybrid work model with 1-2 days per week from home office/remote.
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