Scientific Assistant - Strasbourg, France - Council of Europe

Council of Europe
Council of Europe
Entreprise vérifiée
Strasbourg, France

il y a 3 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

Scientific Assistant

European Directorate for the Quality of Medicines & HealthCare (EDQM)
**Certification of Substances Department (DCEP)

Re f erence
:
e009/2023

Location:
Strasbourg Publication: 11 May 2023


Deadline: 01 June 2023
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry

monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to International Council for

Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), European Union (EU) and EDQM

guidelines, to prepare evaluation reports or provide technical support to the assessment activities and the EDQM inspection

programme of manufacturers of active substances? Then why not give your career a boost by joining our CEP team in

Strasbourg?


Who we are
With over 2200 staff representing all its 46 member States, the

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 the protection of public health by promoting access to safe medicines and healthcare through the elaboration of

quality standards, which are recognised as a scientific benchmark worldwide. These standards for medicines and their

ingredients are compiled in the European Pharmacopoeia and are legally binding in 39 European member States (and the

European Union) but are widely used in the human and animal health sectors across the globe. The EDQM also develops

guidance and standards in the areas of blood transfusion, organ, tissue and cell transplantation and consumer health issues

such as cosmetics and food contact materials. Watch our video for more information.

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 alternative options to

included in it is suitably controlled by the respective European Pharmacopoeia monographs and complies with regulatory

requirements. As part of the CEP procedure, the EDQM conducts risk-based GMP inspections of manufacturing sites covered

by CEPs.


Our work is carried by our values

Your role
Scientific assistants in The Certification of Substances Department (DCEP) perform a combination of the following tasks:

participating in the activities of the DCEP by:

  • undertaking scientific evaluation of requests for CEP revisions in accordance with technical rules and guidelines
(general and specific monographs of the European Pharmacopoeia, ICH, EU guidelines and guidelines adopted by
- the Steering Committee of the Certification procedure);
- participating in monitoring of dossiers, treating notifications, and ensuring compliance with applicable systems and

working rules;accordance with the rules and guidelines (including the monographs of the European Pharmacopoeia, EU
- pharmaceutical legislation and guidelines, as well as EDQM specific policies);
- gathering and analysing scientific data and preparing reports for review; preparing data and participating in
- providing technical support to the EDQM inspection programme of manufacturers of active substances; gathering

data on manufacturing sites and ensuring the links between evaluation and inspection activities;
- managing all activities in accordance with established rules and procedures; communicating regularly with companies;
reporting to the management on the status and progress of activities when problems occur.


What we are looking for

As a minimum, you must:
hold a higher education degree or qualification in a relevant area (for example: pharmacy, chemistry, biochemistry, food
science);
have a minimum of 2 years of relevant professional experience in at least one of the following areas:

  • methods of synthesis or physicochemical analysis of pharmaceutical substances or medicinal products, acquired
either in the pharmaceutical industry, an official medicines control laboratory or a similar organisation, or acquired
- during PhD studies in a relevant field;Technical Document (CTD) Module 3 or Active Substance Master Files (ASMFs) in a licensing authority;(CTD Module 3 or ASMFs) for submission to competent authorities including experience in ensuring compliance
- with regulations during the preparation of submissions;
- have a very good knowledge of one of the two official languages of the
of the other (French);
be a citizen of one of the member States of the
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

be under the age of 65 years.
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