At the European Directorate for the Quality of Medicines & HealthCare (EDQM), more than 450 staff members, representing over 30 different nationalities and dozens of different professions, work together for better health, for all. Our wide-ranging activities - all supporting public health - are made possible by close collaboration with a global network of stakeholders and around 2 000 experts from a wide variety of scientific disciplines. The EDQM’s work focuses on four major areas: medicinal products, substances of human origin, pharmaceutical care and consumer health.The team within which you will work, the Quality, Assurance and Risk Management Section (QARS), is part of the Management Support Division. Its role is to provide assurance, advice and insight aimed at improving the EDQM’s operations and supporting the achievement of its objectives. The section contributes to evidence-based decision-making and strengthens the EDQM’s integrity, transparency and accountability framework. As a Junior Quality Management System Officer, you will:contribute to the management of EDQM quality documentation, in particular:process and draft correspondence, documents, presentations, flow charts, process maps and models, in accordance with instructions;process, format, follow up on and archive EDQM quality documents (e.g. procedures, instructions, forms and records); update the EDQM IT tool for managing quality documents;support document owners in the development, review and maintenance of quality documentation, ensuring that documented information adequately describes activities, complies with applicable quality requirements and effectively supports scientific and technical operations;contribute to normative surveillance by monitoring relevant standards and updating the standards catalogue;contribute to EDQM quality audits, in particular:contribute to the preparation and organisation of internal and external quality audits;plan and conduct quality audits, including defining audit objectives, scope and approach, collecting and analysing information, preparing interview guides, conducting and/or supporting interviews, documenting audit work and contributing to the drafting of audit reports;monitor the implementation of corrective and preventive actions arising from audits and follow up with relevant stakeholders;contribute to the management, analysis and presentation of quality-related data, in particular:assist in the collection, consolidation and analysis of quality-related data, indicators and performance metrics;assist in the preparation of reports, summaries, dashboards and other information for management related to Quality Management System activities;support awareness-raising and communication activities aimed at promoting a culture of quality across the EDQM, in particular:prepare and format communications and information materials, including frequently asked questions (FAQs) related to QARS activities, and publish them on the relevant pages of the EDQM Intranet;provide support for training sessions and quality-related events;contribute to quality risk management and project improvement activities.
Organização internacional