Software Validation Manager | Software-Validierungsmanager*in (Gehalt AT)
apero GmbH Arbeitnehmerüberlassung
Job Summary
As a Software Validation Manager, you will lead an international project team, overseeing the validation of all computerized systems within Pharmaceutical Development. Your role ensures the lean implementation and continuous improvement of Computerized System Validation (CSV) and Compliance (C) standards within the NCE division. You will be responsible for planning, configuring, installing, and testing systems while adhering to GxP and safety requirements. This position involves managing validation activities for complex international and interdisciplinary applications, developing new solutions, and optimizing existing ones. You will also collaborate with global functions to generate and maintain life cycle documentation, and create training concepts for users of validated systems. This hybrid role offers flexibility with 1-2 days of remote work per week after initial on-site training.
Required Skills
Education
Master’s degree (e.g., MBA, MSc) in a scientific or technical field or completed technical or scientific vocational training
Experience
- Several years of professional experience in a scientific or technical field
- Professional experience in validation requirements for computerized systems in a regulated GxP environment (21 CFR Part 11 and ISPE GAMP 5)
- Project management experience
- Leadership experience
Languages
Additional
- Hybrid work model with 1-2 days per week remote work possible after on-site onboarding. Primary work location is Biberach an der Riß, Germany.
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