Compliance Engineer – Reliability
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Onze klant is op zoek naar een centrale compliance-expert die de brug slaat tussen technische installaties en kwaliteitswaarborging binnen een complexe productieomgeving. De rol richt zich op het ondersteunen van engineering- en maintenance-processen door middel van technisch onderzoek en het beheren van kwaliteitsstandaarden.
- Beheren en opvolgen van acties binnen het QMS-systeem voor de afdeling Engineering & Maintenance.
- Uitvoeren van root cause analyses bij afwijkingen aan HVAC-installaties en clean utilities zoals WFI, ROW en procesgassen.
- Opstellen van change controls in nauwe samenwerking met stakeholders zoals productie, QA, QC en system owners.
- Ondersteunen bij de opmaak van CAPA's en waarborgen van de tijdige periodieke review van afdelingsdocumentatie.
- Monitoren van kwaliteits-KPI's en het redigeren van compliance-gerelateerde documentatie voor technische teams.
- Je hebt 5+ jaar relevante ervaring in een technische compliance- of kwalificatiefunctie binnen de farmaceutische industrie.
- Je beschikt over een gedegen achtergrond in kwalificatie met een sterke technische affiniteit voor installaties en processen.
- Je hebt grondige kennis van de geldende regelgeving, waaronder Annex 1, en de pharmacopoeia (EP/USP).
- Je bent communicatief vaardig en functioneert volledig autonoom binnen een complexe, multidisciplinaire omgeving.
- Je bent pragmatisch, daadkrachtig en hanteert een oplossingsgerichte aanpak bij complexe vraagstukken.
- Je bent vloeiend in het Nederlands.
Pluspunten
- Ervaring met Quality Management Systemen zoals Veeva.
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