Your role

 Examples of the tasks :

European Pharmacopoeia Department (EPD), actively participating in the development and maintenance of the Ph. Eur. by:

• drafting Ph. Eur. texts (monographs and general chapters) in close co-operation with experts in the field, reviewing scientific data and information (such as batch data, validation protocols and reports);
• planning and co-ordinating activities and following up actions of your assigned Groups of Experts/Working Parties elaborating and revising Ph. Eur. texts, providing advice to the chairs and experts, as necessary;
• proposing the addition of new items or the revision of existing ones to the work programme, evaluating requests for revision as well as questions received from external users;
• co-ordinating collaborative laboratory studies;
• you may also be required to play an active role in the drafting of validation or verification protocols for methods of analysis to be provided in Ph. Eur. texts.

Certification of Substances Department (DCEP):

• conducting, co-ordinating or contributing to thorough and timely investigations into quality issues that impact the validity of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs);
• participating in the scientific assessment of data related to applications for CEPs in accordance with relevant rules and guidelines; providing support to expert assessors from the national competent authorities reviewing applications;
• taking part in scientific discussions with colleagues, external experts or advisory boards with the aim of reaching consensus.

Quality and Risk Management Section (QRMS):

• ensuring classification of substances according to Classification, Labelling and Packaging (CLP) Regulations;
• co-ordinating reviews of reference standard batch documentation for compliance with current Standard Operating Procedures (SOP)s;
• ensuring that users of reference standards have access to appropriate and up-to-date documentation (i.e. Safety Data Sheets (SDS) and leaflets).
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All Scientific Programme Managers may also perform all or a combination of the following duties:

• co-ordinating scientific studies; carrying out background studies/research; investigating issues, gathering and analysing scientific data, preparing reports and identifying key challenges and next steps; keeping up to date with practices, approaches, technology, etc. relating to their own field of work and incorporating them into activities;
• contributing to the EDQM’s ISO 9001 activities with the aim of maintaining the ISO 9001 Certification of EDQM processes; elaborating and revising quality documentation; undertaking systematic root cause analyses; participating in projects that contribute to the optimisation of working methods and tools and the mitigation of risks;
• responding to stakeholder questions, drafting press releases or scientific papers; developing and maintaining contacts with other scientific staff and with counterparts in relevant industries and scientific and regulatory organisations. Join us and help protect public health in Europe!

What we are looking for in you

• hold a higher education degree or qualification in pharmacy, chemistry or a similar life science domain equivalent to a master’s degree (2nd cycle of the Bologna process framework of qualifications for the European Higher Education);
   
• have at least 4 years’ experience in one or a combination of the following areas:
  • quality control of substances for pharmaceutical use (excipients or active substances) and/or medicinal products;
  • developing methods of analysis of substances for pharmaceutical use (excipients or active substances) and/or medicinal products;
  • preparation or evaluation of the quality part of marketing authorisation applications.

This experience may have been acquired in a licensing authority, the pharmaceutical industry, an official medicines control laboratory, at university (e.g. during PhD studies) or in a similar institution;

• have a very good knowledge of one of the two Council of Europe’s official languages (English) and basic knowledge of the other (French) or the ability to acquire that knowledge on the job.
• Teamwork and co-operation
• Planning and work organisation
• Analysis and problem solving
• Management of teams
• Concern for quality
• Results orientation
• Relationship building

These would be an asset:

• Professional and technical expertise:
• good knowledge of pharmaceutical regulatory requirements, e.g. knowledge of CTD Module 3.
• Resilience
• Adaptability
• Learning and development