Junior Quality Management System Officer

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.
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You must have:

• a higher education degree or qualification equivalent to a master’s degree (2nd cycle of the Bologna process framework for the European Higher Education Area) in quality management, pharmaceutical sciences, chemistry, biochemistry, biotechnology, or a related scientific or engineering discipline (such as process engineering or life sciences);
• at least six months and not more than two years’ relevant professional experience in quality management systems within a regulated environment, e.g. the pharmaceutical, life sciences or food industry, including activities such as quality auditing or document management;
• very good knowledge of one of the two Council of Europe’s official languages (English or French) and good knowledge of the other.

You must also:

• be a citizen of one of the member states of the Council of Europe and fulfil the conditions for appointment to the civil service of that state;
• have discharged any obligation concerning national service (military, civil or comparable);
• not be the parent, child, stepchild or grandchild of a serving staff member of the Council of Europe;
• be under the age of 35 years.

Your application must also demonstrate to what extent you have the competencies listed below. To help you doing so, feel free to consult our competency framework.

• Operational - Planning and work organisation
• Operational - Analysis and problem solving
• Operational - Concern for quality
• Interpersonal - Teamwork and co-operation

• Professional and technical expertise
  • ability to understand scientific and technical processes and to critically review associated documentation in order to ensure compliance with quality management requirements;
  • ability to use standard tools in office applications, particularly Excel (advanced functions), Word and presentation and data analysis software.
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• Operational - Learning and development
• Interpersonal - Communication

This job vacancy is published within the framework of the Junior Professional Programmes (limited to 4 years). You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage What we offer.

For more information on how we recruit, you can consult the page Our recruitment process. This recruitment is carried out in accordance with Articles 490 and 4100 of the Council of Europe Staff Rules. The deadline for applications is indicated in the General information section of this vacancy notice (see above) and is fixed at 23:59:59 (CET/CEST). When applying, make sure your motivation shows how your competencies make your profile the best for the role.

As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified people, irrespective of sex, gender, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunity policy, the Council of Europe is aiming to achieve gender parity in staff employed in each category and grade. At the time of appointment, preference between suitable people shall be given to the person of the gender which is under-represented in the relevant grades within the category to which the vacancy belongs.

Applicants with specific needs are encouraged to request reasonable accommodations at any stage during the recruitment process. Please contact us at talents@coe.int, we will ensure that your request is handled.

The information published on the CoE’s careers website regarding working conditions is correct at the time of publication of the vacancy notice. Any changes to these conditions during the recruitment process will be updated on our Portal and will apply at the time of the job offer. Our career's website is not intended to be exhaustive and may not address all questions you would have. Should you have remaining questions, please contact us at talents@coe.int.