Do you have the skills and experience in quality documentation, auditing and process analysis required to play a critical role in fostering a “quality culture” within the EDQM’s Certification Department (DCEP)? Do you have the potential to provide essential support for the accurate reporting of data that are made publicly available via the EDQM’s website? Are you someone who would be able to work both independently and collaboratively across all levels of the EDQM and within a multidisciplinary team? Would you like to contribute to the activities of an international organisation working for human rights, democracy and
the rule of law? If so, this vacancy may be the right opportunity for you.
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.
The Certification of Substances Department (DCEP) is responsible for implementing the procedure for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP).
Duties of the position
As a Scientific Assistant – Quality and Process Management in DCEP, you will:
- Assist with implementing, maintaining and improving the EDQMs Quality Management System (QMS) across the department:
- manage DCEP’s quality documentation processes, prepare or update quality documents, helping colleagues to write quality documents and ensuring they reflect current practices;
- prepare, participate in and document quality audits together with follow up on resulting actions;
- foster intra- and inter-entity collaboration to improve the EDQM’s QMS as one of the EDQM’s quality correspondents.
- Assist DCEP’s Planning and Process Manager by:
- checking CEP certificates before they are signed, sent to applicants and listed in the CEP database;
- collecting and checking results against performance indicators;
- preparing regular activity reports (including graphical data) for approval and publication on the EDQM website;
- taking part in departmental and/or EDQM continuous improvement initiatives with the aim of eliminating inefficiencies and streamlining processes, as needed.
Required selection criteria
- Hold 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 (chemistry, biology, pharmacy, or other relevant subject) or in quality management;
- have a minimum of 1 year of relevant professional experience in a quality role in the pharmaceutical/chemical industry or a related sector applying standards such as ISO 9001 or GMP;
- have a very good knowledge of one of the Council of Europe’s official languages (English) in oral and written communication and basic knowledge of the other (French) or the ability to acquire that knowledge on the job;
- be a citizen of one of the member States of the Council of Europe and fulfil the conditions for appointment to the civil 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 Council of Europe;
- be under the age of 65 years
If successful, you may be offered employment based on an initial fixed-term period of at least one year, corresponding to the probationary period, at grade B4. After successful completion of a one-year probationary period, which may be extended if needed, the initial contract may be renewed one or several times for a total duration of service not exceeding four years. A fixedterm appointment shall be converted into an open-ended appointment at the end of four years’ continuous service subject to the fulfilment of the conditions established by the Secretary General.
In Strasbourg, you will receive a basic monthly gross salary of €4 687 which is exempt from national income tax. Different salary scales are applied at our external offices according to the cost-of-living conditions. This salary may be supplemented by other allowances depending on your personal situation. You will benefit from the Council of Europe pension scheme, and also from private medical insurance, annual leave and other advantages (including flexible working hours, training and development, possibility of teleworking, etc.).
Organisation/Company –Council of Europe – European Directorate for the Quality of Medicines & Healthcare (CoE EDQM)
Research Field – Biological sciences (Biology Chemistry), Technology (Pharmaceutical technology), Mathematics (Statistics)
Researcher Profile – First Stage Researcher (R1), Established Researcher (R3)
Country – France
Application Deadline – 25 Nov 2024 – 21:59 (UTC)
More information: EUROAXESS
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