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Description & Requirements
The European Directorate for the Quality of Medicines & Healthcare (EDQM) is a leading organisation whose mission is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting acces to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific bookmark worldwide. the EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopeia, are legally binding in its 39 member states (and the European Union) and are also widely used across the globe in the human and animal health sectors. The EDQM also plays a crucial role in the areas of blood transfusion, organ, tissue and cell transplantation and in developing and setting consumer health standards, such as for cosmetics and food contact materials.
The Substances of Human Origin (SoHO) - Quality Section team is responsible for helping to improve the quality systems of blood and tissue establishments across Europe. It works transversally within the SoHO Division and with other entities.
As a Senior Project Officer for the Substances of Human Origin (SoHO) - Quality Management programme, you will focus on:
- co-ordinating the running of a number of scientific events, e.g. training programs, webinars, workshops and conferences/symposiums, by working with external speakers and colleagues across the SoHO Division and the Communication and Events Division – this includes supporting a group of international experts in establishing and developing and rolling out these events and monitoring their impact, particularly that of the training programs;
- co-ordinating Blood Proficiency Testing Scheme (B-PTS) or related studies, including preparing study protocols, in collaboration with the appointed external Scientific Advisor; procuring samples and organising their distribution to participating testing laboratories;
- analysing, evaluating and reporting on results received in collaboration with the EDQM’s statisticians and the external Scientific Advisor;
- contributing to other quality management-related activities such as conducting surveys and drafting quality documents;
- maintaining co-operation with the relevant bodies (e.g. professional associations and societies);
- promoting the activities of the SoHO Division, while keeping abreast of developments in the SoHO field, particularly in quality management;
- helping to prepare the budget for the abovementioned activities and reporting on progress made;
- assigning work to assistants, as appropriate.
You must:
- hold a higher education degree or qualification (equivalent to the 1st cycle of the Bologna process framework of qualifications for the European Higher Education Area) in biology, medicine, nursing, pharmacy or a similar field;
- have at least 3 years of professional experience in a field relevant to the work of the EDQM, including one year gained in the field of quality management in either the SoHO field or in pharmaceuticals;
- have very good knowledge of English;
- have a basic knowledge of French or the ability to acquire that knowledge on the job.
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 65 years.
Your application must 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
- Interpersonal - Service orientation
- Interpersonal - Teamwork and co-operation
- Professional and technical expertise:
- knowledge of the European regulatory requirements in the field of SoHO and/or medicinal product quality management;
- good drafting and communication skills;
- experience in the organisation of training sessions and similar events.
- Operational - Results orientation
- Interpersonal - Adaptability
- Professional and technical expertise:
proficiency in communication/presentation tools;
practical experience in applying ISO 17025 or ISO 17043.
This job vacancy is for an international external recruitment. 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 Article 490 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 [email protected], 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 [email protected].