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External recruitment competition
CEP Revisions Teamleader B5
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Job title: CEP Revision Teamleader B5
Grade: B5
Duty Station: Strasbourg, France
Reference: e55/204
Deadline for applications: 27th November 2024
Do you have proven experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use? Are you able to plan your work effectively to manage multiple assignments with strictly defined deadlines? Do you have the right mix of scientific knowledge and management and communication skills to support junior scientists in evaluating CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) dossiers? If yes, apply now to become one of our Revisions Teamleaders, working to ensure that manufacturers continue to comply with the European Pharmacopoeia and the requirements of the relevant EU legislation.
Who we are
With over 2600 staff coming from all its 46 member States, the Council of Europe is a multicultural Organisation. We all strive towards protecting human rights, democracy and the rule of law and our three core values – professionalism, integrity and respect – guide the way we work.
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 access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific benchmark worldwide. The EDQM’s standards for medicines and their ingredients, compiled in the European Pharmacopoeia, are legally binding in its 39 European 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 Certification of Substances Department (DCEP) is responsible for implementing the procedure for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP). The CEP Procedure is one of three ways to show that the quality of the active ingredients in a medicine is controlled by the European Pharmacopoeia and meets regulatory standards. As part of the CEP procedure, the EDQM conducts risk-based GMP inspections of manufacturing sites covered by CEPs. DCEP works with a network of nearly 150 experts (quality assessors and inspectors nominated by National Competent authorities).
Your role
As a CEP Revisions Teamleader, you will:
- manage a small team of junior scientific assistants; train and coach them by providing scientific expertise and assisting them with the evaluation of dossiers to ensure consistency between evaluation reports for similar products and adherence to guidelines and procedures; assist the Head of the Revisions Section in managing the activities of the section; participate in the activities of the team;
- review assessment reports related to CEP revision and renewal dossiers drafted by junior scientific assistants, within set deadlines;
- participate in scientific decisions taken on dossiers to ensure continued compliance of the substances with the requirements laid down in the relevant monographs of the European Pharmacopoeia and the international guidelines (EU/ICH);
- work and communicate with colleagues, assessors and inspectors in the Department, as well as with other colleagues within the EDQM; from time to time, possibly represent the EDQM in events, conferences, working groups etc;
- participate in the EDQM’s quality management system for CEP related activities.
What we are looking for
You must:
- have a higher education degree or qualification equivalent to a master’s degree (2nd cycle of the Bologna process framework of qualifications for the European Higher Education Area) in science (pharmacy, chemistry, biochemistry, engineering or other relevant discipline) and a minimum of 3 years’ professional experience described below;
Or
- have 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 science (pharmacy, chemistry, biochemistry, engineering or other relevant discipline) and at least 6 years’ professional experience described below;
- have a minimum of 3 years’ (or 6 years’) professional experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use, including methods of synthesis and various analytical methods used for the control of substances, gained either in an authority or in the chemical, pharmaceutical or similar industries;
- have a very good knowledge of one of the official languages (written and oral English) and a basic knowledge of the other (French) or the capacity to acquire the knowledge on the job;
- 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;
- Before applying to this vacancy notice, note that special conditions apply to this profile. Please read this document.
Demonstrate to us that you have the following competencies:
- Professional and technical expertise:
- knowledge of the European Pharmacopoeia and European regulatory requirements for medicines.
- Planning and work organisation
- Analysis and problem solving
- Service orientation
- Teamwork and co-operation
- Resilience
- Learning and development
These would be an asset:
- Concern for quality
- Adaptability
- Management of teams
What we offer
If successful, you may be offered employment based on an initial fixed-term period of at least one year, corresponding to the probationary period, at grade B5. After successful completion of a one-year probationary period, which may be extended if needed, the initial contract may be renewed one or several times for a total duration of service not exceeding four years. A fixed- term appointment shall be converted into an open-ended appointment at the end of four years’ continuous service subject to the fulfilment of the conditions established by the Secretary General.
In Strasbourg, you will receive a basic monthly gross salary of €5 445 which is exempt from national income tax. Different salary scales are applied at our external offices according to the cost-of-living conditions. This salary may be supplemented by other allowances depending on your personal situation. You will benefit from the Council of Europe pension scheme, and also from private medical insurance, annual leave and other advantages (including flexible working hours, training and development, possibility of teleworking, etc.).
This competition is carried out in accordance with Article 490 of the Staff Rules. You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on our recruitment website. Any changes to these conditions during the recruitment process are updated on this site and will apply at the time of the job offer.
Applications and selection procedure
The deadline for applications is 27 November 2024 (midnight Central European Time). Applications must be made in English or French using the Council of Europe online application system. You can create and submit your online application on our website (www.coe.int/jobs). Please fill out the online application form providing all requested details and explain how your competencies make your profile the best for this role. It usually takes a few hours to fill in an application form, so please take this information into consideration while applying.
Only applications that best meet the criteria set out in the Staff Rules and in this vacancy notice, and that demonstrate the best profile in terms of qualifications, experience, and motivation, shall be considered for the next stages of the recruitment evaluation process, which may consist of different types of assessment. The tentative dates for each stage of the recruitment process will be published on our website.
People who perform best in the evaluation process shall be placed on a pre-selection list, valid for four years. Being on a pre-selection list does not give a right to appointment. People on the pre-selection list with the most suitable profile may be invited to an interview to assess their suitability for a specific job and may, if successful, be recommended for the appointment.
