Regulatory and Pharmaceutical Affairs Advisor
Pharmacist graduated from the Faculty of Pharmacy Paris V
MSc 2 "Responsibility and Quality Management in the Health Industries" (Bordeaux)
A pharmacist specializing in quality management for the health industries, Amélie gained her first experience in product support/quality assurance alongside subcontractors on a production site, where she was involved in recording and monitoring claims, managing investigations, tracking quality indicators and carrying out periodic quality controls.
She continued her experience in System Quality Assurance and Pharmaceutical Coordination on an exploitant site within GSK Laboratories, allowing her to develop her skills in various exploitant activities, such as managing Product Quality Claims, Product Quality Reviews and Annual Quality Reviews. She was also involved in the self-inspection process, monitoring and reporting stockouts and updating quality documentation.
Amélie joined ATESSIA in September 2020 as a Regulatory and Pharmaceuticals Consultant on quality management systems, opening and modifying pharmaceutical establishments with the creation of their Quality Management System and writing quality procedures. She is involved in Procurement Disruption processes and Product Quality Reviews (PQRs). She also conducts compliance audits of exploitant and reseller pharmaceutical companies.