Documentation Associate – GMP Compliance Packaging

Responsibilities

• 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

Requirements

• Successfully completed commercial training (kaufmännische Ausbildung) or an equivalent qualification
• Several years of relevant professional experience in the pharmaceutical sector
• Solid knowledge of GMP
• Strong analytical skills and a structured way of working
• Experience working with the SAP ERP system
• Careful attention to detail and enthusiasm for working with Master Data Management systems and processes
• Team player with very good communication skills
• Willingness to work at both our Wedel and Tornesch locations
• Fluent German and very good English skills

Core Competencies

Demonstrates expertise in Master Data Management within the pharmaceutical sector, ensuring compliance with GMP guidelines and effective use of SAP ERP systems. Strong analytical skills and attention to detail support the development of KPIs and cross-functional documentation.