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Summary

Computer Systems Compliance (CSV) with 15 years of relevant experience within the pharmaceutical industry (manufacturing-, R&D-, ICT- and QC/QA- departments). Experience in providing QA-support, project management and execution of validation & compliance projects for various computerised systems, including laboratory systems, IT-applications and manufacturing systems (including 21 CFR Part 11). Certified Validation Manager (ECA, www.gmp-compliance.org) Specialties: • Computerised Systems Validation. • GAMP. • Japanese Sarbanes Oxley (JSOX) Compliance. • FDA. • 21 CFR Part 11. • EudraLex: The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems. • MHRA GMP Data Integrity Definitions and Guidance for Industry, March 2015. • Internal Controls.

Experiences

Current Experience

  • Computerised System Validation Officer
    Since January 2000
    System administrator of following analytical systems: Waters Empower 3, Agilent OpenLAB, Bruker OPUS. System administrator of following manufacturing systems: Siemens PCS7, Emerson Delta-V, ABB Conductor-NT. Testing and validation of analytical and manufacturing systems. Testing and validation of business systems (SAP & Avantis). Performing internal J-SOX audits. Management of process flowcharts, process narratives and process risk control matrices.

Past Experience

  • Quality Assurance & Quality Control Officer
    October 1989 --- December 1999
    Management of QC lab of Fytopharmaceutical products (suspensions, emulsions, wettable powders and granules).

Personality

Self Assessment :
Analytical thinkingAuthenticityIndependenceTrustWillingness to compromise

Knowledge

Self Assessment :
21 CFR Part 11cGMPChange ControlChange ManagementCompliance with regulationsCurrent Good Manufacturing Practice (CGMP)FDAGXPRegulatory ComplianceSearch literature on clinical trialsValidation
LinkedIn Assessment :
ValidationGMPAnalytical ChemistrySOPFDAPharmaceutical IndustryRegulatory affairsComputer System ValidationGXPGAMP21 CFR Part 11J-Sox

Skills and Expertise

Self Assessment :
Create SOPsValidate dataVerify dataWork cross-functionallyDevelop protocolsEvaluate protocols

Education

  • Engineer in Biotechnology from Vrije Universiteit Brussel in 1987
  • Bachelor in Biology from Universiteit Hasselt in 1984
  • in from Koninklijk Atheneum Tessenderlo in 1982

Training and Certification

  • Data Integrity Requirements for a GMP-compliant Data Life Cycle. in 2016 Training
  • Computer System Validation (A Practical Approach). in 2013 Training
  • Computer Validation in GxP Compliance according to GAMP 5. in 2009 Training
  • PLM400 – Business processes in QM. in 2009 Training
  • SAP01 – SAP Overview. in 2009 Training
  • SCM300 – Manufacturing Overview. in 2009 Training
  • Financial Management for “non-Financials”. in 2007 Training
  • Maintaining the Validated State. in 2007 Training
  • The Validation Manager. in 2006 Training
  • Communiceren en Informeren binnen Projecten. in 2005 Training
  • Computer Validation in GxP Compliance according to GAMP 4. in 2005 Training
  • FDA 21CFR Part 11 Guidance. in 2004 Training
  • GxP Management Information Systems Validation. in 2004 Training
  • Key User Training Empower. in 2004 Training
  • LIMS for the Pharmaceutical Industry. in 2002 Training
  • GMP Compliance for Computer Validation. in 2001 Training
  • Opleiding Veiligheidszorgsysteem. in 2001 Training
  • Updating Skills for Windows NT to Windows 2000. in 2001 Training
  • Windows Technical Support Training. in 2000 Training
  • Windows NT Administration Training. in 2000 Training
  • cGMP for Pharmaceutical and Medical Device Industry. in 1999 Training
  • cGMP for Pharmaceutical and Medical Device Industry. in 1998 Training
  • Computer Systems Validation Master class. in 2007 Certification

Languages

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

Area / Region

Tessenderlo, Belgium

Others

Driving License
  • Yes