Doc Auditor responsible for processing and reviewing closing - related documentation at ServiceLink. Supports Doc Auditors and ensures compliance with company and client requirements.
About the role
- Quality Auditor at Organon handling audit programs and compliance inspections. Collaborating with teams to ensure quality and regulatory adherence at the Oss site.
Responsibilities
- Als Quality auditor ben je mede verantwoordelijk voor een effectief en efficient audit-programma.
- Zelfstandig uitvoeren, rapporteren en beoordelen van de responses (CAPA’s) van Walk Through Audits.
- Uitvoeren van end to end audits van processen op de site Oss.
- Facilitatie van audits en inspecties die de site Oss ontvangt van klanten (CMO) global audits, overheden en notified bodies.
- Initiëren en bijdragen aan verbeteringen op het gebied van kwaliteit, productiviteit en veiligheid.
- Rapporteren aan de site lead auditor en samenwerken met het audit-team voor kwaliteits-toetsing over alle GMP gerelateerde activiteiten.
Requirements
- Afgeronde HBO bij voorkeur in een life-science richting.
- Minimaal 2 jaar werkervaring binnen pharma/medical devices, bij voorkeur binnen een audit/QA omgeving
- Ervaring met standaard Office applicaties, bij voorkeur ervaring met ETQ
- Kennis van Pharma, medical devices en combination products GMP regelgeving (EU, US, ICH en andere relevante GMP regelgeving)
- Verdiepte kennis van Organon Quality Systems
- Communicatief vaardig in het Nederlands en Engels, zowel schriftelijk als mondeling en in staat om samen te werken met collega’s op diverse niveau’s (op site en internationaal)
- In staat om continu te leren en kennis van nieuwe regelgeving op kwaliteitsgebied/ industry practices toe te passen in het audit en inspectie readiness programma.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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