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Summary

Computer system validation engineer with a background in life science.

Experiences

Current Experience

  • Validation Engineer for CTG
    Since January 2013
    Change control of existing in-house developed applications and validation of new applications used in preclinical research. Responsible for Compliance/SDLC deliverables, Test design, planning and deliverables. Keywords: CSV, SDLC, GxP, Change Control, Application Lifecycle Management, Business Analysis

  • Regulatory Compliance Engineer
    Since September 2012

Past Experience

  • Validation Engineer for CTG
    October 2012 --- December 2012
    Validation of text verification software, used to compare PDF inserts with their design file. Responsible for Compliance deliverables, SDLC deliverables,Test design, planning and deliverables. Keywords: CSV, SDLC, GxP, Quality Center

Personality

Self Assessment :
Analytical thinkingProblem solvingAttention to detailOptimismEfficiency

Knowledge

Self Assessment :
R&DDrug regulatory authoritiesGood Laboratory Practice (GLP)It skillsMolecular & Cellular BiologyQualificationValidation
LinkedIn Assessment :
Computer System ValidationValidationQuality Assurance (QA)GAMPQuality SystemsGXP21 CFR Part 11Software DocumentationQuality Center

Skills and Expertise

Self Assessment :
Create SOPsManage Quality Management System (QMS) documentationQuality control processProvide trainingWriting regulatory documents

Education

  • Master of Science (MSc) in Molecular and Cellular Biomedical Sciences from Universiteit Antwerpen in 2012
  • Bachelor of Science (BSc) in Biomedical Sciences, General from Universiteit Antwerpen in 2010

Languages

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

Area / Region

Antwerpen, België

Others

Driving License
  • Yes