Software Validation Manager (Above Tariff Salary) | Software-Validierungsmanager*in (Gehalt AT)
apero GmbH Arbeitnehmerüberlassung
Job Summary
This role requires a dedicated Software Validation Manager to lead an international project team focused on ensuring the validation of all computerized systems within Pharmaceutical Development. Key responsibilities include planning, configuration, installation, and testing of systems while strictly adhering to GxP and safety requirements. The manager will handle validation activities for complex international and interdisciplinary applications, create new solutions, and optimize existing applications. A crucial part of the role involves cooperating with worldwide functions to generate and maintain life cycle documentation, and developing training and key user concepts for validated systems. Ideal candidates possess a Master’s degree in a scientific or technical field, professional experience with GxP, 21 CFR Part 11, and ISPE GAMP 5 validation standards, strong project management skills, and fluent English proficiency.
Required Skills
Education
Master’s degree (e.g., MBA, MSc) in a scientific or technical field or completed technical or scientific vocational training
Experience
- Professional experience in validation requirements for computerized systems in the regulated environment of GxP, 21 CFR Part 11, and ISPE GAMP 5
- Leadership experience
- Several years' professional experience (if vocational training is the highest qualification)
Languages
Additional
- Must be able to work hybrid model (1-2 days remote/week) but primary work location is Biberach an der Riß. On-site induction required. No travel or accommodation costs covered for on-site work in Biberach.
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