Work Experience.

Quality Assurance (QA) compliance, Quality Management System (QMS) review – GMDP, and ISO 13485 and ISO 22000.

Responsible Person (“Responsable Technique”) and QPPV in Switzerland.

Management of batch documentation and release of biological and radiopharmaceutical products

Lead of quality and regulatory compliance audits of suppliers, drug manufacturers and distributors 

Project lead and coordinator for qualification of utilities and facilities, ensuring alignment with GMP guidelines and regulatory requirements