Dr. Alexia Soleille

Support of the site quality management of a Contract Manufacturing Organisation CMO

Maintenance GMP compliance Analyse & trend prod. deviations Root Cause Analysis Follow-up Corrective Preventive Actions Manufacturing process improvement Support production: validation, -monitoring, -optimization (expert prefilled syringe) Implementation new Global Standard Procedure Coordination changes Risk analysis (FMEA, PHA tools) Manage Health Authorities inspections Process verification / monitoring KPIs LEAN SIX SIGMA certif. in 06/14 (improve of the syringe' extrusion force)

Responsible of customer satisfaction via interfaces with affiliates and suppliers. Optimization of the complaint handling process. Improvement of trend analysis for management review. Implementation of corrective and preventive actions to improve the quality of the production process. Overview on the Good Manufacturing Practices (GMP) regulations, on the supply chain and manufacturing operational functions missions, and on the various Quality processes.

Medicinal preparations, sales, stock management, relations with wholesaler, insurance files update, narcotic board maintenance.

Several internships in surgery, pediatric, obstetric, pharmacy.

Responsible for maintaining procedure of giving free prescription drugs to doctors, validation of VIDAL monographs, deposit of promotion and variance files.

Responsible for edition of visit-aids, review of questionnaires given to doctors about flagship products.

First insight of pharmaceutical chemistry research.