QA-CSV Specialist

Il y a 5 jours

Beerse, Antwerpen, Belgique Pauwels Consulting Temps plein 70 000 € - 100 000 € Contrat
  • You have a Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences, or a related technical discipline.
  • You bring 4+ years of relevant experience in CSV, validation, and quality assurance within a GxP environment.
  • You possess experience in quality assurance including change control, deviation management, and maintenance of the validated state.
  • You have a good working knowledge of GAMP 5, EU GMP Annex 11, and US FDA 21 CFR Part 11.
  • You bring experience with manufacturing and automation systems such as PLC and SCADA.
  • You're a solution-oriented communicator with the ability to challenge constructively in a collaborative environment.
  • You are fluent in English.

Nice to Haves

  • Experience with Active Directory, SIMATIC Logon, or industrial automation networks.
  • Previous background in data-flow mapping and data integrity risk assessments.
  • Knowledge of Dutch for local stakeholder interaction.