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Philips LAURENT

MARCY-L'ETOILE

En résumé

Mes compétences :
Humour
Leader
Pragmatisme
Rigueur
Title 21 CFR Part 11
Project Management
Internal Audit
System project management
Result analysis
Problem solving
Quality Assurance
Product risks analysis
Microsoft Office
Medical Devices
Manage international team
Important experience
Immunology
ISO 13485
CAPA

Entreprises

  • bioMérieux - IS QA head

    MARCY-L'ETOILE 2014 - maintenant Manage international team ( US and France) 5 people
    Chairperson regarding the respect of the Non Product Software development process for GxP and non GxP projects.
    Administrate CAPA.
    Establish, follow and communicate quality KPI.
    Oversee the IS internal audits.
    Support for external inspections.

  • bioMérieux - System project manager

    MARCY-L'ETOILE 2009 - 2014 Development project of the new VIDAS system generation, leader product for bioMérieux immunology unit. Success launch in May 2013, followed today by new versions.
    IVD biological system project including : biology, software, instrumentation, disposables, internal tools, documentation, support, manufacturing, quality assurance, regulatory affairs, biomathematic, verification, biological and functional validation, marketing, purchasing.
    International development project: France (3 sites), Italie (1site), USA (2 sites), for international launches with priorities Europe, US (FDA), Chine (CFDA)
    between 100 et 200 persons depending the phases, 25 key functions being project team members
    Budget : confidential

    year 2009 : Europe system project managers service manager
    6 persons team manager : individual follow up with their program directors, training plan, career management..
    Recruitment

  • bioMérieux - Quality Engineer (QE)

    MARCY-L'ETOILE 2005 - 2008 • Software QE (2005) then system QE (2006-2008).
    • Respect of Design Control (FDA Quality System Regulation part 820.30)
    • Elaboration of Validation Master Plan for non-product software
    • Follow up of around 10 projects

  • Renault VI - IS consultant Planner & coordinator

    Boulogne-Billancourt 1999 - 2001 Euro switch projects at Renault VI (RVI) company, with OPX2. Test environment definition for this Euro switch.

  • Objet Direct - Co-manager

    1998 - 2004 Management and follow up of employees
    Draw up of quotes
    Flat fee Project Direction (Géodis BM, bioMérieux)
    Recruitments ,

  • COMELOG then DECAN - IS consultant

    1988 - 1998 * SW distributed architecture method consultant,
    * Implementation of Standardized Electronic Data Exchange with RVI supplier ;
    * Implementation of Standardized Electronic Data Exchange at ANOFLEX company ;
    * Business Analyst at Framatome (now Areva) ;
    * Analyst / Developer French Institute of Petroleum for SW applications «request management» and «result analysis» ;
    * Developer for GIE AMT (banks), France Télécom, COJO 92, Ugine Gueugnon, CCMC

  • SI Companies - Consultant

    1988 - 2004 see below

Formations

  • INSA De Lyon

    Villeurbanne 2001 - 2001 DPE

  • INSA De Lyon

    Villeurbanne 2001 - 2001 DPE (Diplomé Par l'Etat)

    reconnaissance par l'état du niveau ingénieur, sur présentation d'un mémoire. Le mien traitait de "Planification, suivi et pilotage d’un projet Entreprise : la Bascule Euro"
    French state recognition of my ingineer level thanks to the dissertation " plan, follow up and steering of a Entreprise project : Euro switch"

  • IUT Lyon 1 - Site De Villeurbanne Doua

    Villeurbanne 1984 - 1986 informatique

Réseau

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