En résumé

Thèse :
Quality Risk Management et Quality By Design appliqués aux essais cliniques : Illustration au travers du Risk Based Monitoring.


Evaluation des pratiques professionnelles sur le repérage du syndrome métabolique chez les patients traités par anti-psychotiques atypiques à risque.

Mes compétences :


  • GlaxoSmithKline - Complaints Coordinator

    Marly-le-Roi 2016 - maintenant
  • Zimmer Biomet - Complaint Engineer

    Haifa 2014 - 2015 • Managed device status, complaint status and product disposition processes and reduced complaint volume to meet crucial corporate Key Performance Indicator metrics for all Capital goods
    • Authored or reviewed more than 1400 complaint investigations from start of employment to present.
    • Authored of more than 50 MDR/eMDR.
    • Handling quality release for repaired products.
    • Conducted product examinations, Root Cause Analysis, Design History Reviews and trend analysis for Capital goods
    • Interfaced with several areas of Zimmer Biomet Surgical Division, including Product Development, Manufacturing, Machines Servicing, Supplier Quality, Purchasing, Regulatory Affairs, Customer Service and Aftersales department.
    • Provided crucial quality feedback regarding common failures and new issues of existing products for new product development, CAPAs and Health Hazard Evaluations.
    • Handling International Recall over 89 countries. Interaction with upper management to take strategical decisions.
    • Author of Post Market Surveillance plan. Update of the Literature Review process. Training to PMS Team.
  • GlaxoSmithKline - Clinical QA Officer Direction Excellence Médicale Opérationnelle

    Marly-le-Roi 2012 - 2013 Systems GCP, GMP and GPPV audits set up;
    Preparation, audit, report (ICF, PSRI, DIL, Documents tracking table, Contracts, Training);
    Set up and update of local Quality Documents; management of CAPA ;
    Design of training material ;
    Training administrator ;
    Optimization of training items diffusion to Medical Direction ;
    Complaints handling
  • Servier - Clincal Operation QA Assist. Manager

    Suresnes 2012 - 2012 External and systems GCP audits set up : preparation, audit, report (TU, SSF, PV,...)
    Set up and update of global and local Quality Documents(SOP, OPM,FORM) (ICF, Checklist,...)
    Handling of GAP Analysis of local Quality Documents
    Improvement of staff member training. Set up of a 2 year continuous training program
    Set up of CAPA according to audits findings
    Test and implementation of a dashboard for CAPA timelines according to the criticality of audit finding (email alerts,...)
    Design of training material (Powerpoint presentation, e-learning modules, Seminar, Workshop, Quizzes)
    Monitoring visits
    Redesign of the QA intranet webpage
  • Pharmacie - Pharmacien Assistant

    2009 - 2014 Purchasing manager for 5 community pharmacies;
    Dispensation of prescription drugs and medical devices;
    Advice to patients;
    Therapeutic education; management of orders from wholesalers or directly from the lab;
    Supervision of apprentices