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Experiences

Current Experience

  • Clinical Quality Assurance Auditor
    Since July 2013

Past Experience

  • Quality Assurance (QA) Manager
    May 2013 --- June 2013

  • Clinical Quality Assurance Auditor
    November 2010 --- April 2013
    As a Quality Assurance Associate I verify that all company quality systems and clinical research activities are compliant with the current regulatory regulations and guidelines applicable in the pharmaceutical research sector (e.g. GCP, GAMP and 21 CFR Part 11 and FDA Guidance Documents, European Directives etc…) and will advise relevant employees about the implementation thereof in the quality system.

  • Kwaliteitsmedewerker Klinische biologie
    March 2010 --- November 2010

  • Qualtiy Assurance Auditor
    October 2006 --- March 2010

  • Trial Logistic Associate
    January 2004 --- January 2006
    - Responsible for review of the required investigator documentation and study documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP - Collect, review, process, and track regulatory & investigator documents required for study site activation -Liaise with applicable IRB/IEC regarding investigator submission/approval issues

Personality

Self Assessment :
Attention to detailCollaborationFlexibilityInterest in knowledgeResponsibilityWillingness to compromise

Knowledge

Self Assessment :
R&D Phase IAdverse Events (AE)AuditingClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsCompliance with regulationsGood Clinical Practice (GCP)
LinkedIn Assessment :
Clinical trialsICH-GCPCROQuality Systems21 CFR Part 11Wine TastingGMPQuality Assurance (QA)Clinical researchGCPSOPEDC

Education

  • in Quality Management from UAMS in 2008
  • post grad in Health care management from KU Leuven in 2005
  • Master in Biomedical Science from KU Leuven in 2004

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Locations I am interested in:
    2200 Belgium
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Antwerp, Belgium

Others

Driving License
  • No