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Current Experience

  • PV and QA associate
    Since August 2014
    Set up and maintain quality system: GDP, GMP Admin batch release Complaints handling (quality problems, adverse events) CAPA management in trackwise Internal audits Preparation and follow up regulatory inspections

Past Experience

  • Process Improvement Manager at GSK
    May 2011 --- July 2014
    o Implement an electronic trial master file o Change management o Organize + give training sessions o Gap analysis + optimize processes o Connect with different departments, stakeholders o Assessment of central study files for 2 large Phase III studies running in about 35 countries + ensure inspection readiness o Set-up and follow up of action plan with study teams (internal + regional) to reach compliance to GSK documentation requirements

  • QA manager + Clinical trial pharmacist Phase 1/2 clinical research unit
    November 2006 --- May 2011
    o Perform internal audits, participate in client audits and inspections of health authorities o Follow up on CAPA (corrective and preventive actions) related to GCP (good clinical practice) o Give GCP training to research unit team o Review and approval of internal procedures + interaction with different stakeholders o Liaise with Belgian health authorities on GCP/GMP regulations. o Distribution, stock and preparation of Investigational Medicinal Products o Coaching of a team of pharmacists and pharmacy assistants


LinkedIn Assessment :
Clinical trialsQuality Assurance (QA)GCPSOPGMPPharmaceutical IndustryCAPARegulatory affairsClinical DevelopmentCROICH-GCPRegulatory submissionsBiotechnologyClinical research


  • Master's degree in Industrial Pharmacy from Katholieke Universiteit Leuven in 2010
  • Master's degree in Pharmacist from Katholieke Universiteit Leuven in 2004
  • in Latin - sciences from College Vita et Pax Schoten in 1998

Area / Region

Antwerpen, België


Driving License
  • No