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Christian SAUVAGE

COLMAR

En résumé

17 années d'expérience au travers la mise en place ou le renouvellement de systeme qualité (ISO - BPL BPC BPF).
Essai clinique phase I -III
Novel drug
formation du personnel
gestion de système qualité
architecture de système qualité
preparation et gestion des inspections

Mes compétences :
Formation
Gestion de projets
gxp
Qualité
Audit
QA management
Preclinical Development
Clinical Research
CAPA
global QA management
gap analysis
consultant selection
Western Blotting
Team Management
Stroke
Staff management
Staff Development and Training
Risk assessment
Responsible for ISO system
R&D
Quality Assurance management
Quality Assurance Manager Development of analytica
Quality Assurance
QA coordination
Project Management
Phase II Clinical Trials
Pharmacokinetics
Oncology
Infectious Diseases
Immunology
Immunoassay
Immunization
ICON French office supervision
GCP
Eczema
Deviations management
Development of nutrition and health product
Data management
Central Nervous System
Biotechnology
Asthma
Antibiotics

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

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