QA-CSV Specialist
Il y a 5 jours
Beerse, Antwerpen, Belgique
Pauwels Consulting
Temps plein
70 000 € - 100 000 € Contrat
Gratuit avec email ou Google
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Gratuit avec email ou Google
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- 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.