CEP Scientific Assistant (Revisions' Team),
Strasbourg, France
Council of Europe
Closing date: Sunday, 23 September 2018
Apply
Vacancy Notice N° e13/2018
CEP Scientific Assistant (Revisions’ Team) (Grade B4)
Directorate General of Democracy (DG II)
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Certification of Substances Department (DCEP)
Closing date: 24 September 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.
Fixed-term contract: the total length of employment under fixed-term contracts will not exceed five years.
** External recruitment procedure organised in accordance with Article 16 of the Regulations on Appointments.
Job mission
Under the authority of the Head of Department, the incumbent provides professional scientific assistance to the procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) 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.Key activities
The incumbent performs the following key duties:
- participates in the validation of applications for certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) at receipt, checks their acceptability; monitors applications and prepares CEPs;
- participates in the scientific evaluation of revisions of CEP applications in accordance with technical rules and guidelines (general and specific monographs of the European Pharmacopoeia, guidelines adopted by the Steering Committee of the Certification procedure, ICH and EU guidelines);
- provides technical support to the EDQM inspection programme of manufacturers; gathers data on manufacturing sites and ensures the links between the evaluation and inspection activities;
- manages all activities in accordance with established rules and procedures; reports to the management on the status and progress of activities and if and when problems occur.
Eligibility Requirements
Only applicants who best meet the following criteria will be considered for shortlisting.
Qualifications:
Qualifications:
- Completed higher education degree/qualification in pharmacy, chemistry, biochemistry or other relevant discipline.
- Short professional experience (minimum 6 months) in the evaluation or in the preparation of dossiers on the quality of substances for pharmaceutical use (CTD Module 3.2.S), or in methods of synthesis or physicochemical analysis of pharmaceutical substances, obtained either in an authority or in the industry.
- Very good knowledge of one of the official languages (English) and basic knowledge of the other official language (French).
- Nationality of one of the 47 Council of Europe member states.
- Under 65 years of age at the closing date of the vacancy notice.
- Candidates must be eligible for employment on this type of profile.*
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 European regulatory requirements in the field of pharmaceuticals;
- sound computer skills of standard tools in office applications. - Planning and work organisation
- Analysis and problem solving
- Concern for quality
- Decision making
- Teamwork and co-operation
- Service orientation
- Professional and technical expertise:
- knowledge and experience of electronic Common Technical Document (eCTD) tools. - Learning and development
- Initiative
- Resilience
Additional information
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 24 September 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.