Providing Quality &
Compliance Consultant services
Leveraging years of technical infrastructure and QA expertise to deliver audit-ready GxP environments for the Basel Life Science Cluster.
Leveraging years of technical infrastructure and QA expertise to deliver audit-ready GxP environments for the Basel Life Science Cluster.
With 17 years of experience at the intersection of software security, infrastructure, and QA, I specialize in the rigorous demands of Life Science Compliance and Computer System Validation (CSV).
Based in the heart of the Basel Life Science Cluster, I bridge the gap between traditional IT excellence and the complex regulatory requirements of Pharma and Biotech. My approach is clinical: data-driven, structurally sound, and meticulously documented to ensure every system is audit-ready and GxP compliant.
On-site presence with full remote capabilities for global compliance projects.
Integrating cybersecurity into validation lifecycles.
Specialized services designed for the rigorous standards of the Basel Pharma environment.
Comprehensive Installation, Operational, and Performance Qualification for laboratory and manufacturing systems.
Defining validation master plans and risk-based testing strategies that align with GAMP 5 principles.
Ensuring ALCOA+ principles and 21 CFR Part 11 compliance across technical infrastructure and cloud systems.
A trajectory from high-availability infrastructure to critical life science compliance.
Translating complex IT architectures into validated, GxP-compliant frameworks. Specializing in cloud infrastructure validation (AWS/Azure) for Life Science entities.
Decade-plus experience managing mission-critical technical environments, network security, and enterprise systems for global organizations.
Engineering high-reliability software solutions with a focus on data security and operational continuity in healthcare settings.
Academic foundation in computational theory and engineering.
Core competency in Good Manufacturing Practice regulations.
Expertise in designing resilient, high-availability cloud infrastructure.
Foundation in networking operations and enterprise connectivity.
Comprehensive training in end-to-end technical support and troubleshooting.
Ready to ensure your technical systems meet the highest standards of Life Science compliance? Let's discuss your next validation project.
