Documentation Associate – GMP Compliance Packaging

Jobtailor; Wedel; Vor Ort; EUR 54.000 - 76.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Master Data Management professional to lead operational MDM in our production environment, ensuring GMP-compliant dossier handling and country-specific regulations. You will act as Key User for the SAP ERP system with an emphasis on MDM and validation documents.

The role includes supporting SAP implementation, creating GMP governing documents, and researching data to support Quality Events. You will develop KPIs and work cross-functionally across departments.

Qualifikationen

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

Aufgaben

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

Kenntnisse

Analytical skills

Attention to detail

Team player

Communication skills

German English

Ausbildung

Commercial training or equivalent

Tools

SAP ERP

Jobbeschreibung

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.