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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