Cep Revisions Teamleader

**CEP Revisions Teamleader**

**European Directorate for the Quality of Medicines & HealthCare (EDQM)
**Re ference**:e055/2024**

**Location: Strasbourg **Publication: 30 October 2024

**Deadline: 20 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
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

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).

**Our work is carried by our values**

**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