- Implementierung, Sicherstellung und Aufrechterhaltung eines effizienten QMS, um die Sicherstellung der Compliance gegenüber GCP, GDP, GMP, GVP am Standort Grenzach zu garantieren.
- Du bist Process Owner für Dokumentenmanagement, Abweichungsmanagement, Changemanagement, Risikomanagement und Dienstleistermanagement (inkl. externer Inspektionen und Quality Agreements).
- Mitverantwortlich für die strategische Ausrichtung der neu geschaffenen Abteilung Affiliate Quality (Enabling Office) im Rahmen der Unternehmensstrategie, der bestehenden Regularien und gesetzlichen Erfordernisse (horizon scanning).
- Übernahme der zentralen Quality Oversight (QA Rolle) für die RPAG inkl. End-to-end Quality Oversight über die GxP-Compliance in der Affiliate.
- Effizienzsteigerung des Qualitätsmanagementsystems durch kontinuierliche Verbesserungen lean, Six Sigma).
- Management, Durchführung und Nachbearbeitung behördlicher Inspektionen im GxP Bereich und Roche-interner Audits.
- Projektleitung und crossfunktionale Zusammenarbeit mit GxP Mitarbeitenden in Grenzach, globalen Einheiten oder anderen Affiliates. Erstellung Business Cases, GxP Risiken, Maßnahmenplan und finanziellen Einfluss des Projektes.
- Lokaler single-point of
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QPPV / Graduated Plan Officer
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EU Qualified Person
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Microsoft Consultant
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ARaymond Network Weil am Rhein, Deutschland Permanent contractAt ARaymond, we create cutting-edge fastening and assembly systems for the machines and products that keep the world moving. · Founded in Grenoble in 1865, and still headquartered in the city to this day, we're a family-run business with a proud history of innovation – including ...
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Microsoft Administrator
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ARaymond Network Weil am Rhein, Deutschland Permanent contractAt ARaymond, we create cutting-edge fastening and assembly systems for the machines and products that keep the world moving. · Founded in Grenoble in 1865, and still headquartered in the city to this day, we're a family-run business with a proud history of innovation – including ...
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Microsoft Consultant
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Raynet GmbH Lörrach, DeutschlandShape the future of ARaymond as part of our global Microsoft Community. You'll join a team at the beating heart of our company's daily operations. And you'll feel valued for what you bring both as a person and professional, thanks to our servant-leadership model that puts your vo ...
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Partner Success Manager
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Corporate Director Marketing
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Quality Excellence Partner - Grenzach-Wyhlen, Deutschland - Roche
Beschreibung
The Position
Was dich erwartet
Als Quality Excellence Partner (m/w/d) bist Du gemeinsam mit den jeweiligen GxP-Schnittstellen für die Implementierung, Aufrechterhaltung und kontinuierliche Verbesserung eines effizienten und harmonisierten Qualitätsmanagementsystems (QMS) verantwortlich. Darüber hinaus förderst und etablierst Du Schnittstellen von der lokalen RPAG zu globalen Einheiten, Netzwerken und anderen Roche-Standorten sowie Divisionen. Zu deinem Tätigkeitsbereich gehört auch:
