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Summary

Lead auditor: - GLP audits: study, process, facility and external service provider audits - GCLP audits: central labs, specialty labs, CAP/CLIA labs, medical labs - ISO-13485 medical device quality systems - IT, CSV, equipment qualification Currently being trained in GCP site audits.

Experiences

Current Experience

  • Program Manager
    Since August 2012
    Audit schedule set-up and maintenance in a global pharmaceutical environment: clinical lab and system audits. Internal and external auditing of: - medical device quality systems (ISO-13485), - laboratory audits: GCLP - ISO-15189 - CAP - CLIA - GLP facilities Supporting client and government inspections

Past Experience

  • Senior Associate/Specialist
    January 2004 --- August 2012
    GLP Quality Assurance (study based, process based and facility audits), OECD and FDA GLPs, CSV/GAMP IT audits, clinical lab audits GCLP-CAP-ISO15189, supplier audits, ISO 9001, risk management. Internal & external auditing (EMEA, US) CAPA handling and follow-up Supporting client and government inspections

  • Program Leader
    February 1997 --- December 2003
    Program responsible: analysis of medicinal preparations, illicit preparations and residual solvents. Sample preparation & analysis (chromatography, mass spectrometry), analyst coaching. ISO-17025 quality system.

Personality

Self Assessment :
AdaptabilityStrategic thinkingSelf-confidenceProblem solvingOptimismIndependenceEfficiencyCritical thinkingAnalytical thinkingTrust

Knowledge

Self Assessment :
Medical devicesQuality Assurance (QA)LaboratoryFDADrug development processBiomarkers Phase I R&DCAPAIt skillsPhases of clinical development (phase I to IV)Preclinical regulations and practicesQualificationRegulatory RequirementsGCPGood Laboratory Practice (GLP)SOPBiochemistryBiotechnologyChemistryClinical trialsIn VitroIn VivoKnowledge of the drug development processPharmaceutical IndustryPharmacokineticsProcess improvementProject ManagementUnderstanding of regulatory guidelines
LinkedIn Assessment :
Good Laboratory Practice (GLP)Pharmaceutical IndustryQuality Assurance (QA)Quality AuditingG(C)LPMedical DevicesISO 13485FDARisk ManagementProject ManagementLife SciencesCAPAProcess improvementISO 9000Scientific Background

Skills and Expertise

Self Assessment :
Implement Quality Management System (QMS)Provide input to process improvement initiativesPrepare external auditsPrepare internal auditsFollow-up of external auditsFollow-up of internal audits Create SOPsEnsure good clinical practice (GCP)Manage laboratory proceduresSolve problems Molecular DiagnosticsAdjust processes and methodsCoachCreate SOPsCollaborate with project teamEnsure data integrityFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentation

Education

  • Master of Science (MS) in Chemistry - Environmental Sciences from Universiteit Antwerpen in 1996
  • Master in Science in Chemistry from Universiteit Antwerpen in 1995
  • Latin - Sciences in from Sint Jozefscollege Herentals in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
French
Professional Proficiency
Spanish
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

België

Others

Driving License
  • Yes