Elodie JI

Regulatory and Pharmaceutical Affairs Advisor

Doctor of Pharmacy
MSc in Responsibility and Quality Management in the Health Industries (Bordeaux)

Elodie has gained quality-related experience in various types of pharmaceutical structures: exploitant (global headquarters and subsidiary), distribution site, risk management and quality unit within a hospital (in a CRPV) and retail pharmacy (ISO 9001/QMS certified).

Within operating establishments, she worked on drafting SOPs, managing Product Quality claims via TrackWise®, managing batch recalls and monitoring internal/external audits. Her knowledge of the drug distribution system allowed her to map a global group’s distribution flows.

She also developed expertise in medical devices, contributing to the renewal of a CE marking certificate by ensuring the quality management system’s compliance with ISO 13485:2016 and the transition to the new European Regulation 2017/745.

Elodie joined Atessia in 2019 to develop activities relating to both the launch and continuous improvement of Quality Management Systems for pharmaceutical establishments such as operators, distributors and entities marketing medical devices. She audits these pharmaceutical establishments’ systems. She is also involved in writing Quality news in the Atessia Intelligence Monitoring Department.

Expertise

Exploitant

Distribution

Quality Management

Medical Devices