Compliance Engineer – Engineering
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Beheren en opvolgen van acties binnen het QMS voor de afdeling engineering en maintenance.
Coördineren van root cause onderzoeken voor deviaties gerelateerd aan systemen en onderhoudsprocessen.
Opstellen van change controls in nauwe samenwerking met stakeholders zoals productie, engineering en kwaliteit.
Ondersteunen bij de opmaak van CAPA-plannen en het waarborgen van tijdige documentatiereviews.
Adviseren van de technische teams bij compliance-gerelateerde documentatie en vraagstukken.
Je beschikt over 5+ jaar relevante werkervaring binnen een soortgelijke functie.
Je hebt een sterke achtergrond in kwalificatie gecombineerd met een uitgesproken technische affiniteit.
Je beschikt over grondige kennis van farmaceutische regelgeving zoals Eudralex, Annex 1, ICH en ISPE richtlijnen.
Je bent communicatief sterk, functioneert autonoom en hanteert een pragmatische, oplossingsgerichte aanpak.
Je bent vloeiend in het Nederlands.
Nice to HavesErvaring met Quality Management Systemen binnen een compliance-gerichte functie.
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