Validation Manager Focus SAP Implementation

Beschreibung

Job Zusammenfassung In dieser Rolle entwickelst du ein effektives Qualitätsmanagementsystem für die SAP-Implementierung, planst Risikomanagementaktivitäten und dokumentierst die Einhaltung der regulatorischen Anforderungen im Rahmen des Projekts. Job Zusammenfassung In dieser Rolle entwickelst du ein effektives Qualitätsmanagementsystem für die SAP-Implementierung, planst Risikomanagementaktivitäten und dokumentierst die Einhaltung der regulatorischen Anforderungen im Rahmen des Projekts. Deine Rolle im Team As Validation Manager Focus SAP Implementation (m/f/x) you are responsible for establishing, maintaining, and continuously developing an effective Quality Management System in compliance with applicable medical device regulations. The focus of the role is the coverage of Computerised System Validation (CSV) and the correct consideration of regulatory requirements within the implementation phase of ZEISS FIT4 SAP S/4Hana Project. You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements. You ensure the compliant implementation and application of MED QMS requirements within SAP-supported processes in cooperation with partner teams. You plan, drive, and document risk management activities across processes and projects. You develop, implement, monitor, and document validation strategies for Computerised System, ensuring compliance with regulatory requirements. You act as a subject matter expert and trusted advisor for quality and regulatory topics within cross-functional teams. You act as interface for in and -external Partners and support all activities regarding CSV. Unsere Erwartungen an dich Ausbildung You have a completed university degree (Master's level) in natural sciences, engineering, business administration, or a comparable qualification. Qualifikationen You possess solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements. You are familiar with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management. You demonstrate a structured and analytical approach and are able to interpret complex technical and business information. You work independently and in a solution-oriented manner with strong communication and organizational skills. You are fluent in English; German language skills are an advantage. Erfahrung You bring extensive years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry. You have proven experience with Computerised System Validation (CSV). You have valid experience with SAP and BPMN 2.0 is a plus. Benefits Work-Life-Integration ⏰ Flexible Arbeitszeiten 🏠 Home Office Gesundheit, Fitness & Fun 🚲 Jobrad Themen mit denen du dich im Job beschäftigst Quality Assurance ERP Software Integrations Metadaten Level: Senior Job Feld: BI, Test/QA Anstellung: Vollzeit Vertragsart: Unbefristetes Dienstverhältnis Arbeitsmodell: Onsite Unternehmenstyp: Etablierte Firma Branche: Industrie, Produktion Ort: Jena | Deutschland

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