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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. 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

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