Location: Strasbourg, Alsace, France
Closing Date: 01 Jan 17
Salary (£): Competitive
Benefits: Excellent, comprehensive and flexible
We are looking for enthusiastic and rigorous scientific assistant to join our Certification of Substances Division. If chosen, you will provide professional scientific assistance to the procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) in accordance with procedures, guidelines and priorities with a concern for quality, efficiency, and accuracy and in compliance with the Council of Europe's values and regulations.
CEP Scientific Assistants (Revisions' Team) (Grade B4) - 5 years fixed term contract
Location: Strasbourg (France)
Reference: Vacancy Notice n° e177/2016
The Council of Europe www.coe.int and its European Directorate for the Quality of Medicines & HealthCare (EDQM) http://www.edqm.eu are looking for an enthusiastic and rigorous scientist to co-ordinate our Blood Proficiency Testing Scheme (B-PTS). The Blood Proficiency Testing Scheme (B-PTS) is a form of external assessment of quality control management systems that uses inter-laboratory comparisons to determine the performance of blood transfusion screening laboratories responsible for testing individual blood donations. This scheme supplements each laboratory's own internal quality control procedures by providing an external measure of their testing capabilities.
What we offer:
- a good insight into the European regulatory framework from the EDQM perspective and the opportunity to work in a leading international organisation in the field of public health protection - the quality standards that our organisation sets for safe medicines and their safe use are recognised as a scientific benchmark not only in Europe, but world-wide;
- the chance to work in an ISO certified, multi-national/multi-cultural workplace - over 20 nationalities work at the EDQM which is situated in the European quarter of Strasbourg;
- highly competitive, income tax free salaries - monthly salary from € 3 858, an attractive benefits package including health insurance and additional allowances such as family and expatriation allowances (as appropriate).
What should you bring to the job:
- completed higher education degree/qualification in pharmacy, chemistry, biochemistry or other relevant discipline;
- short professional experience (minimum 6 months) in the evaluation or in the preparation of dossiers on the quality of substances for pharmaceutical use (CTD Module 3.2.S), or in methods of synthesis or physicochemical analysis of pharmaceutical substances, obtained either in an authority or in the industry;
- professional and technical expertise, planning and work organisation, analysis and problem solving, concern for quality, decision making, teamwork and co-operation, service orientation;
- very good knowledge of one of the official languages (English) and basic knowledge of the other official language (French).
What we will expect you to do here:
- participates in the validation of applications for certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) at receipt, checks their acceptability; monitors applications and prepares CEPs;
- participates in the scientific evaluation of revisions of CEP applications in accordance with technical rules and guidelines (general and specific monographs of the European Pharmacopoeia, guidelines adopted by the Steering Committee of the Certification procedure, ICH and EU guidelines);
- provides technical support to the EDQM inspection programme of manufacturers; gathers data on manufacturing sites and ensures the links between the evaluation and inspection activities;
- manages all activities in accordance with established rules and procedures; reports to the management on the status and progress of activities and if and when problems occur.
More details and information on the recruitment process to apply can be found on our Employment website http://www.coe.int/web/jobs. Applications must be submitted by December 19th, 2016 (midnight Central European Time) at the latest. Please note we only accept applications posted via our online recruitment web-site.
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