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Experiences

Current Experience

  • Qualified Person / Quality Assurance Consultant
    Since November 2013

    03/2016 – present     Responsible Person for distribution, Lundbeck

     

    11/2013 – present     Qualified Person/Responsible Person for distribution, AstraZeneca

     

    • QA Responsible Person for distribution, recall administrator
    • Batch release of investigational medicinal products (packaging)
    • GxP Quality Lead: implementation/improvement of Quality Management System

     

    01/2014 – present      QA consultant, Sanofi, Switzerland

     

    • Assessment of the PQR (Product Quality Review) received from Contract Manufacturing Organisations

     

    08/2015 – 10/2015      Consultant: B&C, Mont-Saint-Guibert

     

    • Batch review (manufacturing and Quality Control) and gap analysis IMPD

     

    02/2014 – 03/2015      QA consultant, Eli Lilly, Geneva

     

    • Resorption of Quality Assurance backlog (change control, deviation, returns)
    • GDP audit of subcontractor
    • GDP training
    • Implementation of the (Risk) Management of suppliers and subcontractors

     

    02/2014 – 02/2015      QA consultant, Peptisyntha, Neder-Over-Heembeek

     

    • Batch review (manufacturing and Quality Control) at the Contract Manufacturing Organization
    • Write and review of product quality reviews

     

     

    11/2013 – 12/2013      Qualified Person, Sanico, Turnhout

     

    • Batch review and certification at the Contract Manufacturing Organization.

Past Experience

  • QO/QC Quality Associate III
    May 2011 --- November 2013

  • RA compliance & Process Quality coordinator
    April 2010 --- May 2011

  • Process Quality coordinator
    April 2010 --- April 2011

Knowledge

LinkedIn Assessment :
GXPSOPLife SciencesQuality AssuranceQuality SystemBPFGMPPharmaceutical IndustryCAPAChange ControlFDAValidation21 CFR Part 11SOPAseptic Processing

Education

  • Master's in Industrial Pharmacy from Ghent University in 2009

Area / Region

Belgium

Others

Driving License
  • No