Scientific Programme Manager – Profile A: Study Director – Analytical Chemistry / Profile B: Laboratory IT / Automation Manager (Grade A1/A2)
Directorate General of Democracy (DG II)
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Laboratory Department
Job mission
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
Key activities
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.
Closing date: 14 June 2016
Location : Strasbourg, France