The seconded official shall remain in employment or be paid by the member State from which he/she is seconded throughout the period of secondment, and shall receive no salary and no social and medical cover from the Council of Europe.
The seconded official shall be entitled, throughout the period of secondment, to a displacement allowance and travel expenses (cf. in particular Article 23 of Committee of Ministers’ Resolution Res (2012)2 for further information).
Under the authority of the Head of the Department, the seconded official will provide professional scientific and technical secretariat, support for the coordination of the Blood Quality Management (B-QM) programme and supervision of the Blood Proficiency Testing Scheme (B-PTS) programme in accordance with procedures, guidelines and priorities, with a concern for quality, efficiency, and accuracy and in compliance with the Council of Europe’s values and regulations.
The seconded official performs the following key duties:
• Leads activities related to developing, implementing and improving Quality Management Systems (QMS) of European Blood Establishments including in collaboration with the responsible Working Group :
- planning, preparing, co-ordinating blood training visits (B-TVs), mutual joint visits (B-MJVs) and mutual joint audits (B-MJA) and auditing; drafts reports on visits and audits and, when needed, follows up the action plan;
- participates in the setting up and maintenance of the Quality Management (QM) system for the B-QM Programme including the coordination of the drafting of guidance documents;
- organises training courses, workshops and conferences; provides lectures on quality matters.
• Co-ordinates/supervises and monitors progress of scientific projects related to the Proficiency Testing Scheme (PTS) activities for blood establishments including the annual programme of PTS studies for blood establishments, with the support by a scientific assistant and in collaboration with the responsible Advisory Group;
• Provides technical and scientific support to assigned experts groups (B-PTS Advisory Group and B-QM Working Group);
• Coordinates B-PTS and B-QM work programmes and monitors progress in both programmes throughout the year;
• Contributes to the implementation of EU/EDQM cooperation agreements and technical reporting to the European Commission;
• Contributes to the preparation and follow-up of the relevant budgets in collaboration with the Head of Section;
• Ensures promotion of the activities; represents the EDQM at conferences and European Commission meetings;
• Ensures implementation and improvement of the EDQM Quality Management System.
Please note that the seconded official may be required to perform other duties not listed in the call for candidates.
Qualifications:
Higher education degree or qualification in pharmacy, biology, or other relevant discipline.
Experience:
At least 4 years of professional experience in the field of regulation/inspection of blood-derived medicinal products or blood transfusion related domains gained either in the pharmaceutical or medical device industry or a competent authority or an international organisation.
Language requirements:
Very good knowledge of one of the official languages (English) and basic knowledge of the other (French).
Nationality:
Nationality of one of the 47 Council of Europe member states.
Essential:
› Professional and technical expertise
- knowledge of the European regulatory requirements in the field of the quality of medicinal products and Substances of Human Origin
› Planning and work organisation
› Analysis and problem solving
› Concern for quality
› Results orientation
› Teamwork and co-operation
› Relationship building
Desirable:
› Service orientation
› Learning and development
For more information, please refer to the Competency Framework of the Council of Europe.