Christian SAUVAGE

En résumé

Entreprises

• Crucell AG - Clinical Quality Assurance Manager

  2013 - maintenant QA management for vaccines project or life cycle management
  Risk assessment and audit plan
  Coordination and realization of audit
  Site audits
  Provider evaluation / audits
  Mock inspection
  CAPA Follow up
  Integration and gap analysis between Crucell system and Jonhson and Jonhson system via SOP review
  Data transparency project

• Basilea Pharmaceutica International ltd - Quality Assurance Specialist

  2011 - 2012 QA management project in oncology, severe hand eczema and infectious disease
  Implementation of quality management system (electronic system)
  QA SOP writing and SOP Review
  QA coordination of audit ( from consultant selection to report per review)
  Inspection coordination MHRA
  Training clinical operation staff.
  Coordination of 26 sites audits for filing process for antibiotics compound
  Set up an five year audit plan for evaluation of clinical operation
  Performed sites audits with third partners and system audits (Regulatory Affairs and Data management)

• ICON Clinical Research SARL - Senior Quality Assurance Auditor

  2007 - 2011 ICON CLINICAL RESEARCH SARL - 92 Sévres ( 140 employees ( 15 project managers - 70 CRAs) - manage one QA auditor
  Lead QA auditor for dedicated sponsor project
  Clinical research project from phase II to IV - ) for worldwide project
  Therapeutic areas in Oncology - Cardiology - Central Nervous System
  Audit realization to ensure compliance and regulatory, ICH GCP requirements (from protocol to final study report) :
  * site (60),
  * Monitoring file, Trial Master file (60)
  * Data management, (4)
  * Safety, medical monitoring process (2)
  * IVRS (1) ;
  * Evaluation of critical supplier dedicated to the project (outsourced CRO, pharmaceuticals services, archiving) (5)
  Lead QA for animal health study (VICH GCP audit).
  ICON French office supervision:
  - Responsible for ISO system for the French office (audit supplier -ISO certification)
  - PM and CRA training dedicated to project and regulatory updates.
  - Coordination for in house inspection or audit. ;
  - CAPA process - Deviation / complain management ;
  - Supplier evaluation fro French office (3) ;

• SPI-BIO - Quality Assurance Manager

  2004 - 2007 SPI-BIO - 78 Montigny le Bretonneux- (Paris area)
  QA staff 2 - manage one QA engineer
  Detached in two services from Commissariat à l'Energie Atomique (French Atomic Energy Commission)
  Neuro-Virology Service (Service de Neuro-Virologie) - 20 persons Thematic: HIV - SIV and TSE and neurodegenerative diseases - Inflammation allergy about 10 - 15 studies per year
  Equipments: Cytometer in flux - ELISPOT - Western blot - PCR - Molecular biology
  Immunology and Pharmacology Service (Service de Pharmacologie et d'Immunologie) : Staff 40 persons
  Thematic : principle active studies on drug and metabolom - pharmacokinetics - in vivo and in vitro models
  About 25- 30 studies per year
  Equipments: Spectrophometers, Chromatography, LC/GC/GC, - Molecular biology
  Good Laboratory Practises Evaluation form pharmaceuticals studies (immunoassay - analytical analyses and method validation)
  Standard Operating Procedures redactions and validation
  Validation performed on analytical process
  Audit from study protocol / study plan to final study report including operational phases.
  Internal processes audit for process compliance in regards with EU directive and other guidelines
  Personal training
  Deviations management and CAPA
  Review of inspection report and sponsor audit and replies in coordination
  Metrology (qualification equipment)

• ASTRAZENECA - Clinical Research Associate

  Rueil-Malmaison 2004 - 2004 ASTRAZENECA - Scientific and Medical Service - 92 Rueil Malmaison (
  Clinical Research Associate Therapeutics Area: Central Nervous System and Pneumology.
  Clinical studies in asthma - migraine - Cerebrovascular accident
  Clinical studies phase II and III
  Monitoring of 4 sites (located in Paris area)

• FRAISNOR SA - Quality Assurance Manager Obtain French agreement production

  2001 - 2002 FRAISNOR SA -Ready-cooked production (pasta production) (100 pers)- Feuchy 62 223 (North area)
  by Ministry of Agriculture
  Obtain Helvetica agreement for commercialisation in Switzerland
  Process validation obtain according HACCP (Hazard analysis Critical Control Point)
  Staff management: 10 persons & Staff training
  Control and validation from raw materiel to production
  Client complain management & Deviation management
  Registration Monitoring

• GLP - Inspector

  1999 - 2001 BIOTEK Agriculture - Pesticide Evaluation (staff 30 pers) - Saint Pouange 10 120 (Champagne area)
  GLP Inspections - (study based inspection - process inspection)
  Act as a quality assurance consultant for agricultural cooperative (quality organisation, HACCP studies on process, quality system )

• Continentale Nutrition - Pet-food Production (45 pers) - Quality Engineer

  1997 - 1999 Continentale Nutrition - Pet-food Production (45 pers) - Wimille 62 126 (North area)
  Quality Engineer Obtain French agreement production by Ministry of Agriculture
  Obtain ISO 9002 certification & Etude HACCP study
  Personal training
  Process validation & Auto control validation
  Deviation management
  
  
  
  
  DIPLOMAS & HIGHER EDUCATION

Formations

• UFR Des Sciences Pharmaceutiques

  Caen 2004 - 2004 DU Recherche et Développement cliniques des médicaments

• Université Des Sciences Et Technologie De Lille USTL

  Lille 1989 - 1992 chimie biologie

Réseau

• Auclair VINCENT

• Aurélia GAUTRET

• Caroline REIS

• Célia BRUNET

• Christelle MOREAU

• Diane MOREAU

• Laurie PASCHIER - THIBAUDAT

• Maud GORDAT

• Pierre ENGEL

• Sarah SURMONT