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.
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
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
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.
AdaptabilityStrategic thinkingSelf-confidenceProblem solvingOptimismIndependenceEfficiencyCritical thinkingAnalytical thinkingTrust
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
Skills and Expertise
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
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