CEP Revisions Team leader B5
- Employer
- Council of Europe EDQM
- Location
- Strasbourg (Ville), Strasbourg-Ville (FR)
- Salary
- €5445 per month (gross)
- Closing date
- 27 Nov 2024
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- Sector
- Chemistry, Manufacturing, Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
Grade: B5
Salary: €5445 per month (gross)
Location: Strasbourg (France)
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 Teamleaders, working to ensure that manufacturers continue to comply with the European Pharmacopoeia and the requirements of the relevant EU legislation.
Let’s work together for better health, for all!
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 and click here to find out why you should join the EDQM.
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 and click here to find out why you should join the EDQM.
Company
With over 2000 staff representing all its 47 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 is a leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. For medicines, the European Pharmacopoeia’s quality standards are legally binding in 38 European member States and used in over 100 countries worldwide. To apply these standards the EDQM stocks and supplies around 3000 different reference substances mainly for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia. Similarly, the guidance and standards in the areas of blood transfusion, organ, tissue and cell transplantation, pharmaceutical care and consumer health issues such as cosmetics and food packaging materials are recognised throughout the world.
- Website
- https://www.edqm.eu/en/
- Location
-
Strasbourg
France
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