Your responsibilities
- Setting up, maintaining and further developing our digital quality management system in accordance with § 52a AMG, AM-HandelsV and the EU GDP guidelines
- Ensuring compliance with all medicines legislation
- Point of contact for authorities (for example the Bezirksregierung, the regional government), auditors and inspectors; preparing and accompanying GDP inspections and audits
- Creating and controlling SOPs, work instructions and the QM manual, including version control
- Assessing deviations, CAPA measures and change control processes
- Quality assurance in goods receipt, temperature-monitored storage, picking and dispatch
- Handling complaints, recalls, stock blocks and quality defects
- Planning, delivering and documenting staff training (GDP, QM, hygiene, processes)
- Close cooperation with management, warehouse, purchasing, sales and external service providers