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Klaus Kildebæk Rasmussen

Senior Consultant

QMS Systems | Validation of packaging and assembly equipment

Summary

Since 1996 Klaus has been working with many aspects regarding special designed assembly and packaging equipment within pharmaceutical and medical device production. Klaus has experience from supplier’s and customer’s point of view regarding project management, CE documentation, QMS systems, process risk assessment, user requirement specifications and commissioning/validation of packaging and assembly technologies within special equipment manufacturing, pharmaceutical production and medical device production.

As a person Klaus is thorough, responsible, conscientious, broad minded and humorous and is seeking practical and simple solutions to professional challenges.

Special Competences

  • Validation of packaging and assembly equipment
    • Performing process FMEA
    • Writing URS
    • Writing commissioning/validation documentation
    • Performing commissioning/validation tests.
  • QMS Systems
    • Writing procedures, instructions and SOPs.

Project Experience

  • Pharmaceutical Production, Automatic Inspection and Packaging of Vials • URS.
    • Process FMEA.
    • Risk Assessment.
    • Design Qualification.

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Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?
Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?