Regulatory and Pharmaceutical Affairs Advisor
Doctor of Pharmacy - Ph.D
MSc 2 "Responsibility and Quality Management in the Health Industries" (Bordeaux)
As a pharmacist specializing in quality management for the health industries, Amélie gained her first experience in quality management / product support on a production site, where she was involved in managing quality complaints, piloting investigations, tracking quality indicators and carrying out quality periodic reviews.
She continued her experience in Quality System Assurance and Pharmaceutical Coordination within the exploitant site of GSK France, allowing her to develop her skills in various exploitant activities, such as managing Product Quality Complaints, Product Quality Reviews and Annual Quality Reviews. She was also involved in the self-inspection process, monitoring and reporting of stock shortages and reviewing quality documentation.
Amélie joined ATESSIA in September 2020 as Regulatory and Pharmaceuticals Affairs Advisor to take part in missions related to quality management systems, opening and modifying pharmaceutical establishments with the creation of their Quality Management System and writing quality procedures. She is involved in stock-out management processes and Product Quality Reviews (PQRs). She also conducts compliance audits of exploitant and wholesaler pharmaceutical companies.