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Contact Info
EDQM Recruitment
Council of Europe EDQM

+33 (0)3 88 41 20 00
[email protected]
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Program Manager
Westmeath
QA Specialist
Limerick
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Details

CEP Revisions’ Team Supervisor


Reference:edqmCEP Location: France
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: See description
May be suitable for: QA Supervisor
CEP Revisions’ Team Supervisor


Grade: B5


Contract Type: Renewable fixed term contract


Location: Strasbourg (France)


Reference: Vacancy Notice n° e27/2020
Deadline for applications: 26/08/2020


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 deal with multiple assignments with strictly defined deadlines? Do you have the right mix of scientific knowledge, coaching and communication skills to support junior scientists in evaluating CEP dossiers? If yes, apply now to become one of our Revisions’ Team Supervisors, working to ensure that manufacturers continue to comply with the European Pharmacopoeia and the requirements of the relevant EU legislation.
The main responsibilities of the job:
Within the Certification of Substances Department, the successful applicant will supervise the work of a group of scientists within the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) Revisions Team. Other responsibilities include:
  • eviewing assessment reports related to CEP revision and renewal dossiers drafted by junior scientific assistants,;
  • participating 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);
  • cooperating with other colleagues within the EDQM on various projects;
  • participating in the EDQM’s quality management system and the maintenance of the ISO 9001 certification for Certification related activities.

What we look for in someone to undertake this role effectively:

  • completed higher education degree/qualification in pharmacy, chemistry etc. at least 3 years professional experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use, including methods of synthesis and of various analytical methods used for the control of substances, gained either in an authority or in the chemical or pharmaceutical industries.
  • preferably experience in management of small teams.
  • very good knowledge of one of the two official languages (English) and knowledge
  • of the other official language (French).
What we offer:
  • a good insight into the European regulatory framework from the EDQM perspective; experience of evaluating a wide range of pharmaceutical substances produced by manufacturers worldwide; exposure to the documentary standards required by European regulatory bodies.
  • the chance to work in an ISO 9001 certified, multinational/multicultural workplace – over 20 nationalities work at the EDQM which is situated in the European quarter of Strasbourg (a UNESCO World Heritage site).
  • highly competitive, income tax-free salaries (4 788 €), an attractive benefits package including health insurance, additional allowances such as family and expatriation allowances (as appropriate) and an annual training programme.
Applications must be submitted by 26/08/2020 (midnight French Time) at the latest.