Scientific
Assistant
Grade: B4
Salary: €4 442 per
month (gross)
Reference: Vacancy Notice no e9/2023
Deadline for applications:
01/06/2023
Would you like to build a career in regulatory
affairs? Do you have excellent chemical synthesis or analytical chemistry
skills? Do you have the scientific expertise required to check the
acceptability of applications for Certification of Suitability to the
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? This job offer may
be the right opportunity for you.
Scientific assistants in The Certification
of Substances Department (DCEP) perform a combination of the following
tasks:
- 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; - contributing to the validation of CEP applications
on receipt, checking their acceptability (format and content) in 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
decision-making processes; monitoring applications and preparing CEPs; - 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 offer:
- International Working Environment
- Flexible Working/ Teleworking
- Private Health Insurance
- Holidays, wellbeing and work-life
balance - Sustainable working environment
- Attractive tax-free salary
Let’s work together for better health, for
all!
If you meet the eligibility criteria and are a
citizen of one of the 46 member States of the Council of Europe, please submit
your application using our online recruitment website
to find out why
you should join the EDQM.
For more information on how to apply,
please visit our website via the button below.
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