Basel, Basel, Switzerland
At Roche Diagnostics Europe, the focus is on upholding system integrity and compliance within the medical devices and pharmaceutical manufacturing sphere, a challenge I've embraced with over 9 years in computer systems validation (CSV) and quality management. The expertise developed through roles at Legacy-Pharmaceuticals and GSK is now pivotal in my current position, where process improvement and adhering to stringent quality standards are part of the daily ethos. The team's dedication to innovation and precision underpins Roche's standing in the diagnostics field. My contribution is grounded in a commitment to regulatory excellence, ensuring that our solutions meet the highest levels of quality assurance. Together, we are advancing the forefront of medical diagnostics, reinforcing Roche's global reputation by continually enhancing our manufacturing processes.
Test/Validation Lead, implementation coordinator of a production and laboratory access control validated computerized system.
Validation of ERP, cloud based Learning Manangemenst System, Medical Device Software, IT Development Tools, Document Management System, Labeling system, Product Lifecyle Management System.
Project: Global Remediation of CSV Quality