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Experiences

Current Experience

  • Regulatory Compliance Consultant
    Since November 2015

  • Validation Consultant for CTG Belgium
    Since November 2015
    Executing periodic reviews of IT GxP validated systems within the IT compliance solutions department. Performing gap analysis on system documentation, consulting regarding action plans to be put in place.

Past Experience

  • Regulatory Compliance Consultant
    September 2012 --- April 2015
    current assignment: Quality Engineer @ J&J Clinical Pharmacology Unit

  • Quality Engineer @ J&J Clinical Pharmacology Unit
    September 2012 --- April 2015
    Responsible for quality management maintenance, development and continuous improvement, optimizing the CPU processes and quality systems. Assuring the internal processes supported by systems, people and procedures comply with regulations. Maintain inspection readiness, facilitate audits and inspections at CPU. Set up, execute and reinforce programs for CAPA and Deviation handling, Risk management, Internal audits and management review.

  • researcher
    May 2010 --- August 2012
    Support new product initiatives and commercial initiatives on in-market products (dish washing liquids dept.), acting as the connection between product developers, marketing and supporting functions. Develop and validate test methods and SOPs to determine, compare and demonstrate product performance. Coach lab personnel on accurate execution of these methods in line with SOPs.

  • Master's Thesis Internship
    January 2010 --- June 2010
    Revision of HACCP and PreRequisite Program - integrate pharma-validation Master’s thesis: Integration of pharmaceutical validation and HACCP

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailFlexibilityKindnessProblem solvingReaction to stressSociabilityCollaboration

Knowledge

Self Assessment :
Quality ManagementCAPA Phase I R&DClinical pharmacologyClinical trial audits and inspectionsClinical trialsFDAGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH-GCPInformed Consent ProcessIt skillsMicrosoft OfficeSOPTrainingValidationWriting Study Procedures and SOPs
LinkedIn Assessment :
Quality SystemsValidationRegulatory ComplianceCoachingQuality ManagementProject ManagementGCPGMPRisk ManagementQuality Assurance (QA)Procedure DevelopmentCAPATrackwiseEnglishBiotechnologyProduct developmentLife SciencesTrainingICH-GCPR&D

Skills and Expertise

Self Assessment :
Create SOPs Guide students Report dataAdjust processes and methodsCoachCollaborate with medical teamDevelop ICH/GCP compliant processesEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesGuide staffImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Oral presentationPrepare internal auditsProvide trainingRespond to audit findingsSolve problemsTrain on site staffWritten presentation

Education

  • Master in Industrial Sciences - Biochemistry from Groep T - Internationale Hogeschool Leuven in 2010

Languages

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

Area / Region

Belgium

Others

Driving License
  • Yes