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Experiences

Current Experience

  • Ass. Quality Systems Manager Leiden, Nederland
    Since September 2009

Past Experience

  • Quality manager Hoofddorp, Nederland
    November 2006 --- August 2009

  • Clinical Research Associate (CRA) Capelle aan Den IJssel, Nederland
    February 2003 --- November 2006

  • Clinical Research Associate (CRA) Breda, Nederland
    May 2001 --- January 2003

Personality

Self Assessment :
Innovative thinkingFlexibilityApproachabilityCreative thinkingProblem solvingStrategic thinking

Knowledge

Self Assessment :
R&DClinical trial audits and inspectionsClinical monitoringClinical operationsClinical researchDrug Safety and PharmacovigilanceGCPGood Clinical Practice (GCP)ICH GCP guidelinesICH-GCPMicrosoft ExcelMicrosoft OfficePhases of clinical development (phase I to IV)PowerPointProblem-solving methods and troubleshootingProcess improvementQuality Assurance (QA)SOPWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Create SOPs Interpret data Report dataAdjust processes Adjust processes and methodsCollaborate with project teamCreate standard operating procedure (SOP)Create SOPsDevelop ICH/GCP compliant processesDirect co-workersFollow-up of Quality Management System (QMS) processesFollow-up of quality assurance activitiesFollow-up of external auditsFollow-up of internal auditsImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationOrganise meetingsProvide input to process improvement initiativesProvide trainingQuality control processReview quality control activitiesReview quality policiesSet-up quality policiesSolve problemsWritten presentation

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    9 weeks
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl employee :    80% FTE
  • International:
    No

Area / Region

Rotterdam, Nederland

Others

Driving License
  • No