medac group

Compliance

• Responsibility for operational Master Data Management in the production environment, ensuring consistent compliance with dossier requirements, country-specific regulations and applicable GMP guidelines
• Serve as Key User for the ERP system with a focus on Master Data Management, including preparation of validation documents
• Support the implementation of SAP with a focus on MDM
• Create and revise cross-functional GMP governing documents, e.g. SOPs and manufacturing instructions (Master Batch Records)
• Conduct document and data research, e.g. to support the handling of Quality Events
• Develop and define KPIs

Documentation Associate – GMP Compliance Packaging

Designer

• Modify and create print-ready layouts for packaging in accordance with regulatory requirements
• Technical review of print files
• Implement and adapt brand and product designs
• Contribute to overarching project and process initiatives
• Liaise with internal stakeholders

Media Designer, Graphic Designer

QA Engineer

• Mitarbeit bei der Erarbeitung und Verbesserung der abteilungsspezifischen Workflows in eQMS
• Mitwirkung an der Erstellung und Überarbeitung zugehöriger, qualitätsrelevanter Dokumente
• Vorbereitung und Durchführung von Schulungen zu den qualitätsrelevanten Prozessen
• Ganzheitliche Begleitung von Abweichungen und CAPA-Prozessen
• Steuerung des Change-Control-Prozesses
• Mitarbeit an global ausgerichteten Projekten zur Weiterentwicklung von Qualitätsstandards und -prozessen

Documentation Associate – GMP Compliance Packaging

Media Designer, Graphic Designer

QA Manager – elektronisches Qualitätsmanagementsystem, eQMS