Ingrid ELBILIA

En résumé

Entreprises

• PharmaSys - Senior Consultant

  2012 - maintenant STRAGEN – Geneva (on going): Microsoft Access Database Validation - Regulatory Affairs
  
  • Quality Assurance and Validation - Support & Coaching
  
  SERVIER – Suresnes (on going): Validation Projects Coordinator in Clinical R&D
  
  • Datawarehouse - R&D Studies Referential interfaced with multiple incoming and outcoming applications via the BizTalk gateway: Sharepoint sites, CTMS, CDMS, Multi-projects management tool, Randomization tool, Clinical studies reports application, etc.
  
  • Legacy Data Migration from another validated system
  
  SANOFI – Montpellier: Periodic Review Leader
  
  • Automated clinical supplies chain for assembling and packaging “patients’ kits” –HH at the Montpellier site
  
  • Chromatographic Data Manager System (CDS) that acquires, processes, reports and manages chromatographic information.
  
  SICPA – Lausanne: Product Sterilization and Supply Chain
  
  • Audit in preparation of an internal inspection: Enterprise organisation, Projects lifecycle, Operational processes and Computerized Systems (from the development until the FAT).
  
  
  MAQUET – Ardon: Validation Projects Manager – All GxP Computerized Systems (3 Months)
  
  1/ Audit, support & coaching to SI Validation (in preparation of FDA inspection)
  
  2/ Validation of 30 critical GxP Computerized Systems:
  
  - Excel tools & Macro: managing Complaints, Risk Management Dossier, CAPA, Audit Follow-up, Temporary Intervention Records, Supplier Assessment Planning, Analysis and reporting of production defaults (indicators), Traceability of all technical modification requests.
  
  - Web Quality Assurance Portal: publish and make all the quality documents available to the employees of Maquet Enterprise (standard operating procedures, forms, news, etc.).
  
  - Non conformities management tool (MAGIC): from the customer complaint to the processing and resolutions.
  
  - Preparation of release orders (PREPCOM): ensuring the orders integrity and the traceability of all products delivered.
  
  
  SERVIER – Suresnes: Validation Projects Coordinator in Clinical R&D (12 months)
  
  1/ Datawarehouse SAS Business Intelligence – Programs developed using Agile methodology (XP)
  
  - Validation of the upgrade from SAS 9.1.3 to SAS BI 9.2 platform,
  - Quality Assurance supervision & coaching (documentation, new procedures implementation, pilot test realisation checking the process of SAS standard programs development and validation,
  - SAS programs Migration from SAS 9.1.3 platform
  
  2/ SharePoint sites
  
  - Development of a synthetic validation (platforms 2007 and 2010)
  
  3/ Clinical Trial Authorization Management Tool: keep validated system and Periodic review
  
  
  SERVIER – Orleans: Laboratory Information Management System (LIMS)
  
  - Data consultation tool interfaced with a LIMS
  
  
  NOVARTIS – Rueil-Malmaison: Electronic Management tool of Promotional and Non promotional elements
  
  - Collect User Needs and Constraints related to regulatory data management of promotional elements,
  - GxP regulatory review of target system,
  - Presentation of the Zinc interface implementation, technical limits and impacts on the others existing interfaces to software editors (Zinc and Staci)
  - Quiz and action items submission to software editors in order to prepare the Zinc interface implementation,
  - Definition of key steps and migration prerequisites
  - Project planning management
  

• AxDaNe - Junior Consultant

  2007 - 2011 ORPHAN EUROPE – La Défense: Pharmacovigilance Database Validation (9 months – European Project)
  
  - ES1 Safety Manager tool validation including the collect of User Requirements
  - SOPs writing (logical safety, physical safety and administration and setting of the pharmacovigilance database)
  - Project planning management (planning, resources, deliveries, meeting minutes)
  - Audit Supplier and audit report delivery
  
  
  SANOFI AVENTIS – Chilly Site: Oracle AERS and BOxi Validation (2 months - International Project)
  
  - Oracle AERS : PSURs, CTASRs and working documents
  - BOxi: INDAR, Signal Detection, Audit SMA Q&C, Reconciliation Data reports
  
  WYETH – La Défense: Electronic Data Management System (15 months – International Project)
  
  1/ « User Connection Log » module validation (used to track connections on SDL Trados tool)
  
  2/ E-Labeling tool validation interfaced with the translation tool (SDL Trados)
  
  - Update of User Requirements document
  - End user Trainings to SDL Trados 2006 and xmLabeling v4.0.3 tools
  - Validation supervision and coaching
  - Labeling documents creation (in XML format) and PIM files Electronic Submission tests to the EMA
  
  PIERRE FABRE – Boulogne: Pharmacovigilance Database Validation (7 months)
  
  - ARGUS Safety v4.2 Validation
  - Audit of “Workflow” settings (headquarter and affiliates) for ICSRs and Reporting rules
  - Registration management E2B – EMA
  
  SERVIER – Courbevoie : Pharmacovigilance Database Validation (5 months)
  - ARGUS Safety v4.1 Validation
  

Formations

• Université Paris 6 Pierre Et Marie Curie

  Paris 2005 - 2006 Neurosciences & Pharmacologie Clinique

Réseau

• Alexandra ROUSSEAU

• Amélie BOUILLY

• Armand BAULE

• Franck FILLOL

• Grégoire DE LA BONNELLIÈRE

• Jerome GRANDIN

• Landry BONNET

• Laurent FLIPO

• Romain OUCHET