Kiona Harbers

Qualification & Validation Lead (CQV) at Lonza Netherlands, former PharmaCell
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Contact Information
us****@****om
(386) 825-5501
Location
Maastricht, Limburg, Netherlands, NL
Languages
  • Dutch Native or bilingual proficiency
  • English Full professional proficiency
  • German Elementary proficiency
  • French Elementary proficiency

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Credentials

  • ISO 13485:2016 Lead Auditor (QMS)
    Irish Quality Centre
    Nov, 2019
    - Nov, 2024
  • ISO 13485:2016 Internal Auditor (according to ISO 19011:2018)
    Allanta vzw
    Apr, 2019
    - Nov, 2024
  • MDD to MDR Transition Training Course
    BSI
    Dec, 2018
    - Nov, 2024
  • Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course
    BSI
    Oct, 2018
    - Nov, 2024

Experience

  • Lonza Netherlands, former PharmaCell
    • Netherlands
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Qualification & Validation Lead (CQV)
      • Nov 2021 - Present

      Key tasks: - Lead the CQV team of the Engineering Department - Ensure the building of new standards and ways of workings - Ensure the qualified and validated status of the equipment portfolio - Draft the necessary validation documentation such as IOQ and PQ protocols for the validation of GMP equipment, facility and/or systems within Lonza Netherlands. Key tasks: - Lead the CQV team of the Engineering Department - Ensure the building of new standards and ways of workings - Ensure the qualified and validated status of the equipment portfolio - Draft the necessary validation documentation such as IOQ and PQ protocols for the validation of GMP equipment, facility and/or systems within Lonza Netherlands.

  • Medtronic
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality System Specialist
      • Aug 2019 - Nov 2021

  • Technomed, Medical Accessories
    • Netherlands
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • QA Engineer
      • Oct 2018 - Jul 2019

  • Lonza Netherlands, former PharmaCell
    • Netherlands
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Validation Engineer
      • Nov 2016 - Oct 2018

  • Job-Flow
    • Netherlands
    • Human Resources Services
    • 1 - 100 Employee
    • Junior Recruitment Consultant Life Sciences
      • Feb 2017 - Jul 2017

  • ELITechGroup
    • France
    • Medical Equipment Manufacturing
    • 200 - 300 Employee
    • Verification & Validation engineer | R&D Lab Technician
      • Nov 2010 - Jul 2015

  • Genetwister Technologies B.V.
    • Netherlands
    • Biotechnology Research
    • 1 - 100 Employee
    • Sr. Research Assistant Molecular Biology
      • Feb 2009 - Jan 2010

  • GD Animal Health
    • Netherlands
    • Veterinary Services
    • 300 - 400 Employee
    • Lab. Technician Microbiology
      • Oct 2006 - Jan 2009

  • Wageningen University & Research
    • Netherlands
    • Research Services
    • 700 & Above Employee
    • Student (MSc-thesis) & Research Assistant
      • May 2005 - Jan 2006

  • NIOO-KNAW
    • Netherlands
    • Research
    • 100 - 200 Employee
    • Student (BSc-thesis) and lab technician
      • Nov 2002 - Aug 2003

  • Wageningen University & Research
    • Netherlands
    • Research Services
    • 700 & Above Employee
    • Student & technician
      • Jan 2000 - Oct 2002

Education

  • Wageningen University & Research
    -
    2003 - 2006
  • Van Hall Larenstein University of Applied Sciences
    BSc
    2000 - 2003

Community

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