FIXED-TERM CONTRACT

Under the authority of the Director of the European Directorate for the Quality of Medicines & HealthCare and the Head of the Laboratory Department, the incumbent plans, implements and assesses scientific programmes in order to ensure the quality of medicines in accordance with policies, guidelines, quality management system, priorities and deadlines.

* External recruitment procedure organised in accordance with Article 15B of the Regulations on Appointments

The incumbent performs the following key duties:

Profile A

• Prepares, co-ordinates and plans laboratory projects; prepares and reviews test protocols; prepares laboratory reports including:

• contributing to the development of analytical methods and evaluation procedures to define qualitative and quantitative attributes of substances, preparations and methods;
• providing analytical (technical and scientific) expertise in the participation of the elaboration of suitable solutions to analytical (technical and scientific) problems in the laboratory and in respect of the establishment/production of reference standards;
• gathering and assessing information on attributes, quality and use of substances for pharmaceutical use and pharmaceutical preparations;
• contributing to the work of Groups of Experts and Working Parties of the European Pharmacopoeia Commission;
  • Advises and reports to manager on progress, results achieved, further requirements, complex and/or sensitive cases and identifies appropriate adjustments to improve working methods;
  • Coaches and motivates staff, evaluates their performance, fosters co-operation and team spirit, encourages team to achieve the objectives;
  • Attends and participates in meetings, conferences etc.;
  • Contributes to the maintenance of the Quality Management System based on the new ISO 9001 standard.

Profile B

• In close collaboration with the EDQM’s IT service

• manages and maintains the LIMS (Laboratory Information Management System) and contributes to its interfacing with the ERP (Enterprise Resource Planning System), the SDMS (Scientific Data Management System), ELN (Electronic Laboratory Notebook) and oversees the CDS (Chromatographic Data - System);
• monitors the proper functioning of IT platforms running laboratory applications; provides assistance, troubleshoots and advises on CDS/LIMS/SDMS/ELN and connection of instruments to the laboratory IT network;
• establishes network specifications and ensures network compatibility and connectivity for laboratory analytical instruments by acting as the liaison person between the laboratory and the EDQM’s IT service;
  • Leads the Steering Committee of the Department Information/Automation and Working Groups dealing with developments related to CDS, LIMS and SDMS/ELN; participates in the elaboration and execution of the laboratory Information/Automation strategy; and keeps abreast of developments in the field;
  • Contributes to the development of the laboratory process as a member of the laboratory management team;
  • Advises and reports to manager on progress, results achieved, further requirements, complex and/or sensitive cases and  identifies appropriate adjustments to improve working methods;
  • May coach and motivate staff, evaluates their performance, fosters co-operation and team spirit, encourages team to achieve the objectives;
  • Contributes to the maintenance of the Quality Management System.

Please note that the incumbent may be required to perform other duties not listed in the vacancy notice.

Only applicants who best meet the following criteria will be considered for shortlisting.

Qualifications:

Higher education degree or qualification (equivalent to the first cycle of the Bologna process framework of qualifications for the European Higher Education Area) in pharmacy or chemistry (or similar subject).

Experience:

Profile A

• At least 4 years professional experience in physical-chemical analysis, including at least 2 years practical experience in a laboratory adhering to GMP (Good Manufacturing Practices) or ISO 17025 acquired in an official medicines control laboratory, at University (e.g. during PhD studies), an analogous organisation or the pharmaceutical or related industries.

Profile B

• At least 4 years professional experience in analytical laboratories (official medicines control laboratories, standard-setting organisations, University (e.g. during PhD studies), or pharmaceutical, cosmetic, food or similar industry), including at least 6 months as the administrator of at least one of the following laboratory Information/automation applications: CDS, LIMS, SDMS and ELN.

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.

Age:

• Under 65 years of age at the closing date of the vacancy notice.

Council of Europe staff members adhere to the values Professionalism, Integrity and Respect.

Essential:

Profile A

• Professional and technical expertise:

• demonstrated knowledge of, and competencies in, laboratory processes and extended knowledge of the physical-chemical analytical techniques employed to characterise the quality of substances for pharmaceutical use and medicinal products;
• knowledge of laboratory Information/Automation applications such as Chromatographic data systems (CDS) and Laboratory Information Management System (LIMS).
  • Management of teams
  • Analysis and problem solving
  • Planning and work organisation
  • Teamwork and co-operation
  • Results orientation
  • Concern for quality

Profile B

• Professional and technical expertise:

• demonstrated knowledge of laboratory processes and bench level knowledge of the main analytical techniques employed in a modern pharmaceutical analysis laboratory (e.g. LC, GC, UV, FTIR, titrations, pH; mass spectrometry etc);
  • Management of teams
  • Planning and work organisation
  • Analysis and problem solving
  • Teamwork and co-operation
  • Results orientation
  • Service orientation

Desirable:

Profile B

• Management of teams

For more information, please refer to the Competency Framework of the Council of Europe.

Applications

Applications must be made in English or French using the Council of Europe on-line application system.  By connecting to our website www.coe.int/jobs you can create and submit your on-line application.  Applications must be submitted at the latest 14 June 2016 (midnight Central European Time).

The selection procedure consists of shortlisting, assessment(s), and a panel interview. Assessments may include one or more of the following: ability tests, behavioural questionnaires, job-related examinations, situational exercises, language tests, interviews and full assessment centres. At least one assessment will be eliminatory.

Depending on the number of applicants, the length of the required professional experience may be increased.

Candidates with the best results in the previous stages of the procedure (tests, exams, etc.) will, as a last stage of the procedure, be invited for an interview with a panel.

Following this competition, a reserve list of successful candidates, in order of merit, may be established. This list will be valid for two years with the possibility of extending it to a maximum of four years. It should be noted that placement on a reserve list does not give candidates the right to an appointment within the Council of Europe. The choice of candidates from a reserve list is not made solely according to the order of merit but also takes into account the requirements of the position to be filled and the qualifications of the candidates.

During the period of validity of the reserve list, candidates on the list may be offered employment on a fixed-term contract, which may be renewed one or several times. There is a statutory probationary period of two years.

The compulsory retirement age is 65.

Details on conditions of employment including salaries, allowances, pension scheme and social insurance can be consulted on our recruitment website.

Under its equal opportunities policy, the Council of Europe is aiming to achieve parity in the number of women and men employed in each category and grade. In the event of equal merit, preference will therefore be given to the applicant belonging to the under-represented sex.

The Council of Europe welcomes applications from all suitably qualified candidates, irrespective of gender, disability, marital or parental status, racial, ethnic or social origin, colour, religion, belief or sexual orientation.

During the different stages of the recruitment procedure, specific measures may be taken to ensure equal opportunities for candidates with disabilities.

The Organisation

The Council of Europe is the continent’s leading organisation in the protection of human rights, democracy and rule of law. It was founded in 1949 in order to promote greater unity between its members  and  now includes 47 member states, all having signed up to the European Convention on Human Rights.

By Statute, the Council of Europe has two constituent organs: the Committee of Ministers, composed of the member states’ Ministers for Foreign Affairs, and the Parliamentary Assembly, comprising delegations from the national parliaments. The Congress of Local and Regional Authorities of Europe represents the entities of local and regional self-government within the member states. The Commissioner for Human Rights is an independent and impartial institution within the Council of Europe mandated to promote the awareness of and respect for human rights in member states.

The European Court of Human Rights is the judicial body which oversees the implementation of the Convention in the member states. Individuals can bring complaints of human rights violations to the Strasbourg Court once all possibilities of appeal have been exhausted in the member state concerned.

The Council of Europe has its permanent headquarters in Strasbourg (France) and in addition it maintains external presence in more than twenty countries. More information about the Council of Europe external presence.

The European Directorate for the Quality of Medicines & HealthCare (http://www.edqm.eu) is a leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. Its standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia is legally binding in European member states. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantations and consumer health issues. Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect human and animal health.