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• Preparation, review and approval of qualification documents for production equipment
• Conducting and documenting risk analyses at equipment level
• Initiating, processing and reviewing compliance activities such as non-conformities, CAPAs and CCOs

Standard Operating Procedures (SOPs): Develop, review, update, and maintain SOPs while effectively training production teams on compliance and quality best practices....

• Sicherstellung der Betriebsbereitschaft, Funktionsfähigkeit und Werterhaltung von Produktionsmaschinen inklusive der Dokumentation
• Koordination von Störungsanalysen, Fehlerbehebung, Reparaturen, Wartungs-, Instandhaltungs- und Kalibriermaßnahmen

As the operational lead for Life Science & Healthcare in Germany, you ensure compliance with all applicable GDP, GxP, quality, and regulatory requirements while maintaining effective governance frameworks....

• Perform Supplier Quality Risk Assessments and Classifications.
• Prepare, negotiate, and implement Quality Assurance Agreements based on supplier risk classification.
• Define requirements for Receiving Inspections and participate in the sample approval process with Supply Chain and R&D.

• Develop, maintain, and continuously improve our QMS in line with standards such as IFS and customer requirements
• Use QMS tools to manage workflows, documentation, and non-conformance processes
• Prepare, coordinate, and support internal and external audits