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Laurent COQUEBLIN

WAVRE

En résumé

Mes compétences :
Audit
computer
Formation
Informatique
Training
Validation
Validation informatique

Entreprises

  • GSK Vaccines - Sr Manager QMS - Quality & Compliance R&D

    2011 - 2014

  • GSK Biologicals - Global Industrial Operations - Global QA Senior Specialist Quality Systems

    Marly-le-Roi 2010 - 2011

  • GSK Biologicals - GCRD Global Quality & Risk Management - Process Document Manager

    Marly-le-Roi 2007 - 2010 Health Economics
    Epidemiology
    Clinical

  • GSK Biologicals - World Wide Clinical Development - Clinical SOP Coordinator

    Marly-le-Roi 2006 - 2007

  • GSK Biologicals - Global International Operations - TS Validation Supervisor

    Marly-le-Roi 2003 - 2006 - Analytical / Automated systems

    - Computer Validation trainings for internal and external customers.

    - Computer validation activities for automated and analytical equipments

    - Rationalization and optimisation of validation deliverables regarding commissioning, cost and quality – Implementation of a Risk Assessment methodology

    - Creation/review/updates of SOP's

    - Key Computer Validation contact during regulatory inspections

    - Computer Validation supplier audit coordination, methodology and roll-out

  • GSK Biologicals - Global International Operations - QA Supervisor Computer Systems Compliance

    Marly-le-Roi 2001 - 2003 - Computer Validation Internal audits & supplier audit coordination and roll-out

    - Computer validation activities for plant automated and analytical equipments

  • I.R.I.S. Group - Quality Officer

    1999 - 2001 - Successful ISO 9001 certification of two subsidiaries in the group (120p)

    - Implementation and management of the quality system (electronic document management)

    - Training, empowering employees for achieving certification implementation & deadlines

  • I.R.I.S. Clinical - Quality Assurance Coordinator

    1998 - 1999 - Implementation of the quality system in compliance with GCP and ISO 9001 norm.

    - Software Validation plan

    – Key contact during pharmaceutical industry client’s audits (Parexel US, AstraZeneca D)

    – Work in collaboration with german, american and canadian business partners.

  • SGS Biopharma - Quality Assurance Auditor

    1998 - 1998 - Quality control of CRF & Study Master Files.

    – Review of ICH GCP + GLP procedures

  • LFB (laboratoire Français du Fractionnement et des Biotechnologies - Responsable Ordonnancement des Laboratoires QC

    1996 - 1997 - Implementation of the unit (Interface between Production/Laboratories/Regulatory Affairs/Subcontractors).

    - Management of a 3 people team.

  • SANOFI DIAGNOSTICS PASTEUR - Quality Assurance – ISO 9002 & Calibrage & Mesures

    Paris 1995 - 1995

Formations

Réseau

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