Vacancy Notice N° e8/2018
Product Safety Specialist (Scientific Assistant) (Grade B4)
Directorate General of Democracy and Human Dignity (DG II)
European Directorate for the Quality of Medicines & HealthCare (EDQM)

Quality, Safety & Environment Division (QSED)
Closing date: 28 May 2018
Location : Strasbourg

Fixed-term contract: The total length of employment under fixed-term contracts will not exceed five years.

Job mission

Turnover profile

Turnover profiles are specific roles where it is considered to be in the best interests of the Organisation to have a consistent rotation of staff. Turnover profiles offer once-only opportunities under this scheme and the total duration of employment cannot exceed five years.

Staff members or former staff members who are or have previously been employed in the framework of the Junior Professional Programme or Turnover Profiles will not be eligible again for any of the profiles under these schemes. The Council of Europe reserves the right to assess the admissibility of candidates who are or have previously been employed with the Organisation according to their contractual situation at the closing date of this competition.

Job mission

Under the authority of the Head of Division, the incumbent ensures regulatory compliance of chemical and biological materials in accordance with procedures, guidelines and priorities and with a concern for quality, efficiency and accuracy, and in compliance with Council of Europe’s values and regulations.

 

Key activities

The incumbent performs the following key duties:

  • assesses all new chemical and biological materials received by the EDQM against the policy for hazardous materials to propose a classification compiles Safety Data Sheets (SDS);
  • prepares information for users of Reference Standards about classification of hazardous materials;
  • assesses critical quality attributes of reference standards;
  • prepares batch release decisions and related documents (e.g. leaflets);
  • develops and updates Frequently Asked Questions (FAQ) for users and responds to their questions;
  • contributes to the continual development of the Quality Management System and relevant IT systems (e.g. SAP EH&S module and Lisam ExESS software).

 

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

Eligibility Requirements

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

 

Qualifications and Experience:

  • Higher education degree or qualification (equivalent to the first cycle of the Bologna process framework of qualifications for the European Higher Education Area) in an area related to the activities of the post (e.g. pharmacy, chemistry, biochemistry, biology, toxicology) and at least 6 months relevant professional experience in a similar function preferably within the pharmaceutical, chemical or cosmetic industry or a respective regulatory authority;

OR

  • Completed full course of general secondary education and appropriate professional qualifications in an area related to the activities of the post (e.g. pharmacy, chemistry, biochemistry, biology, toxicology) and at least 3 years of relevant professional experience in a similar function preferably within the pharmaceutical, chemical or cosmetic industry or a respective regulatory authority.

Language requirements:

  • Very good knowledge of one of the official languages (English or French) and knowledge of the other.

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.

Admissibility:

  • Candidates must be eligible for employment on this type of profile. Staff members or former staff members who are or have previously been employed in the framework of the Junior Professional Programme or Turnover Profiles will not be eligible again for any of the profiles under these schemes. The Council of Europe reserves the right to assess the admissibility of candidates who are or have previously been employed with the Organisation according to their contractual situation at the closing date of this competition. 

Employee Core Values

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

Competencies

Essential:

  • Professional and technical expertise:
  • knowledge of the Classification, labelling and packaging of substances and mixtures (CLP) regulation (mainly classification) and professional expertise in drafting and monitoring of SDS in the chemical, pharmaceutical, cosmetic or similar environment.
    • Planning and work organisation
    • Analysis and problem solving
    • Service orientation
    • Teamwork and co-operation
    • Adaptability

 

Desirable:

  • Professional and technical expertise:
    • experience in the batch release of pharmaceutical, chemical, cosmetic products gained in the chemical/pharmaceutical/cosmetic industry;
    • knowledge of REACH Regulation;
    • knowledge of SAP EH&S module and/or Lisam ExESS software;
    • knowledge of the ISO 9001.
  • Concern for quality

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

Additional information

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 28 May 2018 (midnight French Time).

 

Any false statements knowingly made by applicants in their application for employment or at the time of their engagement will result in the termination of their employment by the Council of Europe.

 

The selection procedure consists of a shortlisting based on candidates’ applications and may include ability tests, behavioural questionnaires, a job related written exam, situational exercises, language tests, interviews and full assessment centres.

 

Only candidates who best match the requirements of the job vacancy will be shortlisted and invited to test or a written exam. Tests or written exams may be eliminatory, in which case only candidates who succeed in the tests will be invited for interview. Depending on the number of applicants, the length of the professional experience considered for shortlisting may be increased from that indicated in the vacancy notice.

Following this competition, a list of eligible 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. During the period of validity of the list, candidates on the list may be offered employment of fixed term duration. It should be noted that placement on this 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.

 

The first two years of employment will constitute a probationary period. Provided the staff members’ work is considered satisfactory, he/she may be offered a contract of fixed term duration. However, the total length of employment will not exceed five years. The staff member so recruited shall not be eligible for any subsequent internal competition, promotion or transfer to a post, or for secondment.

 

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 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.