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Summary

more than twenty years experience in Engineering, Validation & quality activities for the bio-Pharmaceutical Industry. since october 2012, manager of a global quality team dedicated to develop and deploy technical quality expertise in facility and production processes within gsk Vaccines network. main development: process Validation under new approach (FDA guideline 2011). other domains (Validation and control strategies): facilities, clean utilities, cleaning, Sterilization (including gamma radiation), single-use-systems, container closure integrity.

Experiences

Current Experience

  • Global QA - Head of Facilities & Production Processes


    Since October 2012

Past Experience

  • Global Validation Manager

    August 2007 --- October 2012

  • Validation Manager

    February 2005 --- July 2007

  • Project Manager - Process and Compliance

    September 1998 --- January 2005
    Engineering and Validation

  • Validation Specialist

    September 1997 --- August 1998

  • Head Operator

    April 1996 --- June 1997

  • Project Manager

    January 1990 --- September 1995

  • Workshop Manager (Coating - Painting)

    October 1987 --- January 1990

  • Production Technician (plating gold, nickel, tin-lead)

    April 1985 --- September 1987

Knowledge

LinkedIn Assessment :
GMPValidationGAMP21 CFR Part 11BiotechnologyVaccinesQuality Assurance (QA)CAPABiopharmaceuticalsAseptic ProcessingSOPGXPComputer System ValidationChange ControlFDACleaning ValidationTechnology transferSOP

Education

  • in Chemical Engineering from Université Paul Sabatier (Toulouse III) in 1982

Area / Region

Wavre, Belgique

Others

Driving License
  • Yes

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