Administrative and Technical Officer (Quality Assurance for Medical Products)
Title: Administrative and Technical Officer (Quality Assurance for Medical Products)
Duration: Long-term, full-time contract
Starting date: ASAP
Deadline for applications: 15 September, 2017
- MSF INTERNATIONAL
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters. MSF offers assistance to people based only on need and irrespective of race, religion, gender or political affiliation.
MSF International is the legal entity that binds MSF’s 21 sections, 24 associations and other offices together. Based in Geneva, MSF International provides coordination, information and support to the MSF Movement, as well as implements international projects and initiatives as requested.
- POSITION BACKGROUND
MSF has established a standardised approach to ensure the quality assurance (QA) of the medical products we use in our projects, i.e. medicines, medical devices and specialised medical food. This approach relies on other approval systems such as WHO prequalification or registration in countries with stringent health regulatory authorities and includes the full evaluation of the quality of the products not covered by existing systems. For vaccines, we rely on the WHO prequalification. The MSF Quality Assurance is organised under 3 coordinations for the following categories of products: pharmaceuticals, medical devices including in vitro diagnostic tools and specialised medical food
III. PLACE IN THE ORGANISATION
The officer is part of the IO medical team, coordinated by the International Medical Coordinator.
Reporting lines: The officer reports functionally to the International Pharmacist Coordinator (IPC), the QA Coordinator for Medical devices, and the International Food QA Coordinator and hierarchically to the International Medical Coordinator.
The time spent for each type of medical product areas shall be shared with the following ratio among the different areas: medicines 35%, medical devices 35% and specialised food 30%. Taking into account that the workload may be different within the three areas during the course of each year, activities may be adapted according to the period, preferably at the year planning stage, always ensuring good communication among the coordinators and with the officer.
IV. OBJECTIVES OF THE POSITION
The officer manages the databases for medical products and assists the three QA coordinators in implementation of the quality assurance strategy for medical products.
V. MAIN RESPONSIBILITIES
- Administer the Quality Assurance databases (pharmaceutical, medical devices and specialised food) and administer the MSF QA document repository systems
- Centralise all the information regarding the quality of medical products (manufacturer dossier, product dossier, monitoring, variation, technical visits, audits correspondence, claims, batch recalls upon request, etc.), and manage the relevant databases (including in Unidata), for the users e.g. ESC pharmacists and QA referents, IS pharmacists, OC pharmacists, etc.)
- Be the focal point for development of end user specifications of IT tools for medical product data management (such as Unidata).
- For Medical Devices, participate to the preparation of annual reports related to medical products such as purchase analysis and quality complaints summary.
- Product dossiers for international procurement
- Request medical product dossiers to manufacturers and screen for completeness according to SOP.
- Assist the international coordinators for MD and specialized food for dossier review upon request
- Monitor the product dossiers to ensure accuracy of information (variations, updates).
- QA Management System
- Assist the 3 QA Coordinators in developing, implementing and maintaining Quality Management System documentation, for a continuous improvement.
- Propose specific areas for harmonization of the three QMS for medical products to the coordinators, and be in charge of their implementation under the supervision of the coordinators.
- Administrative support for the QA Coordinators:
- Organize meetings when requested:
- Book the rooms, send invitations, update the lists of participants, etc.
- Take minutes of meetings when requested
- Maintain the internal network mailing lists: google groups (MSF international and IMES) as well as access rights to document repositories
- Follow-up yearly subscriptions (US Pharmacopeia, BP Pharmacopeia, etc.)
- Distribution of pharmaceutical data and documents within the MSF pharmaceutical network
- Be in charge of the possible development and maintenance of the share point as collaborative work tool and sharing of information tool.
- Assist in recruitment processes as required
- Undertake other duties as required
- Undertake other activities related to the ones outlined in previous points, as per evolving needs.
- PROFILE REQUIREMENTS
- Genuine commitment to MSF’s humanitarian principles, social mission
- Experienced in database management
- Experienced in Quality System Management
- Experience in pharmaceutical, medical device and/or food safety environment is a plus
- Knowledge of medical/public health matters, preferably in a humanitarian / development environment.
- Previous experience in similar position is a plus
- English and French read, written, spoken - Very good English writing skills
- Software skills: Excel, Word, Power Point
- Able to work with the necessary precision and rigor requested
- Outstanding organisational skills
- Ability to manage tasks simultaneously and to work independently
- Ability to work in a multi-cultural environment
- Flexibility, availability to travel
Starting date: ASAP
Contract: Full time, long term
Deadline for applications: 15 September 2017
Please submit all applications only by email to:
IOfirstname.lastname@example.org stating “Admin and Technical Officer -QA coordination” in the title.
Please submit your CV and cover letter in
ONE file and name the file with your LAST NAME.
-Only short-listed candidates will be contacted-