Computer System Validation (CSV) | CSA | Quality Assurance | GxP | Data Integrity | ALCOA | Regulatory | EudraLex | 21 CFR |...

With 25 years of professional experience in the GMP environment, I have contributed across multiple departments, with a strong focus on quality management throughout the value chain.

• 21 CFR
• ALCOA
• Consultant
• CSV / CSA
• Datenintegrität
• EudraLex
• Good Manufacturing Practices
• Qualitätsmanagement / QS / QA (IT)
• Technisches Qualitätsmanagement / QS / QA

With 25 years of professional experience in the GMP environment, I have contributed across multiple departments, with a strong focus on quality management throughout the value chain. My expertise lies in Quality Assurance (QA) and Computerized System Validation and Compliance (CSV&C), ensuring that quality standards are embedded at every stage — from development and implementation of systems to operational use and continuous improvement.
I am responsible for overseeing computerized systems and ensuring data integrity across systems, procedures, and user behavior. My role includes managing validation processes and deliverables to align with both internal quality frameworks and external regulatory requirements. By integrating quality principles into cross-functional workflows and digital system landscapes, I help ensure traceability, consistency, and compliance across the entire value chain.
My work involves international collaboration, expert consultation, and thought leadership, including publications as a recognized authority in CSV.