Computer System Validation Manager | Validation Manager - Computersysteme (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
As a Computer System Validation Manager, you will serve as a critical interface between specialized departments and quality assurance, acting as the primary point of contact for internal and external audits within the pharmaceutical and life sciences sector. Your daily responsibilities include initiating GMP-compliant system changes, managing system validations, and maintaining documentation throughout the software lifecycle while ensuring strict adherence to Data Integrity requirements. You will be instrumental in establishing and improving existing processes and providing expert guidance on qualification questions across various departments. This role is ideal for proactive professionals who enjoy shaping digital transformation processes in a regulated environment. The position offers attractive benefits such as mobile working options, professional development opportunities, and a company pension scheme, all while working on exciting projects for prestigious pharmaceutical clients.
Required Skills
Education
Completed university degree in a scientific, technical, or business field with a strong technical understanding and IT affinity.
Experience
- Professional experience in Computer System Validation (CSV) preferred
- Experience working within the pharmaceutical industry or life sciences environment
- Demonstrated experience in applying cGxP requirements and regulations
- Proven experience in professional communication with internal and external global stakeholders
- Experience in creating and maintaining validation and software lifecycle documentation
Languages
Additional
- Must have a proactive personality with an interest in process design; ability to work in a global environment; mobile working available depending on client requirements.
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