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Council of Europe - European Directorate for the Quality of Medicines & Healthcare (CoE EDQM)
Offer Description CEP Revisions Team Leader
Council of Europe - European Directorate for the Quality of Medicines & Healthcare (CoE EDQM)
Strasbourg, France
Grade: B5
Salary: €5445 per month (gross)
Reference: Vacancy Notice n° e55/2024
Deadline for applications: 27/11/2024
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 Team leaders, working to ensure that manufacturers continue to comply with the European Pharmacopoeia and the requirements of the relevant EU legislation.
As a CEP Revisions Team leader, 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 offer:
International Working Environment;
Holidays, wellbeing and work-life balance;
Private Health Insurance;
Sustainable working environment;
Flexible Working/Teleworking;
Attractive tax-free salary.
If you meet the eligibility criteria and are a citizen of one of the 46 member States of the Council of Europe, please submit your application using our online recruitment website.

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