Validation Manager - Computer Systems | Validation Manager - Computersysteme (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This role is ideal for a proactive professional passionate about the pharmaceutical and life science sectors, focusing on digital transformation and regulatory compliance. The Validation Manager acts as a critical interface between specialized departments and Quality Assurance, serving as the primary contact during internal and external inspections and audits by authorities and customers. Key responsibilities include initiating GMP-compliant system changes, creating and maintaining robust validation documents for computer systems, and ensuring strict adherence to Data Integrity and cGxP requirements. The manager will also be responsible for establishing and improving existing processes and documentation, and overseeing the lifecycle management of validated software systems. Candidates should possess a relevant technical or scientific degree, experience in Computer System Validation (CSV), and excellent communication skills for engaging with global internal and external stakeholders, contributing actively to process shaping.
Required Skills
Education
Completed degree in natural sciences, technology, or business with technical understanding and IT affinity
Experience
- Professional experience in Computer System Validation (CSV)
- Experience in the pharmaceutical environment and application of cGxP requirements (desirable)
- Knowledge in laboratory organization (advantageous)
Languages
Additional
- Not specified
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