Assistant to QA Coordinators
Duration: long term contract, 100%
Start date: September 2015
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.
MSF has established standardised approach to ensure the quality assurance (QA) of the medical products we use in our projects (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.
PLACE IN THE ORGANISATION
The assistant will be part of the IO medical team, coordinated by the International Medical Coordinator.
Reporting lines: The assistant reports to the International Pharmacist Coordinator (IPC), the QA Coordinator for Medical devices, the International Food QA Coordinator.
OBJECTIVES OF THE POSITION and FORESEEN EVOLUTION
The assistant will manage the databases for medical products and give some administrative and logistical support to the three (3) QA coordinators.
All the components are of varying intensity during the year and over the years to come, in line with the development of the MSF codification project and the revised database for medical products. Currently there is an operational pharmaceutical database that should be maintained and prepared for transfer into the new version. After this transfer, the role of the assistant will still be to update the database with regular updated information, even though more pharmacists will also input data in the database. For medical devices, the database needs to be developed based on the model of the pharmaceutical one, and for specialised food items, the database is currently maintained by the International Food QA coordinator. Both medical devices and specialised food databases will progressively develop following the same model as the pharmaceutical one.
Maintain the Quality Assurance databases (pharmaceutical, medical devices and specialised food) and administer the MSF document repository systems
for the three (3) QA databases: centralise all the information (dossiers, audit, reports, PASS, PSS, DOE, correspondence, review, and according to requirement, claim, batch recall etc), when needed enter it into the database and make sure it is available for the pharmacists involved (eg ESC pharmacists)
Prepare and maintain documentation
- Perform a first dossier screening at reception for completeness in support of the three (3) QA coordinators,
- Codify/archive the product dossier and audit reports (print / electronic versions), bioequivalence studies, products samples, manage the PSS and DOE lists
- Archive and reference documents and emails regarding the qualification of products (validation/devalidation emails, relevant summary tables such as the disease focused ones)
- Support QA coordinators in implementing and maintaining the quality management system
- Support QA coordinators to ensure that quality assurance records, files, data and other documentation is organized and managed efficiently.
Support the three (3) QA coordinators in the following activities:
Organize and follow-up of all QA evaluation steps
- Prepare, organize and follow-up international GMP audit of manufacturing sites
- Follow up product dossiers
- For medicines:
- Organize the International Medicines Evaluation Sessions (IMES), allocate reviewers team, track deadlines, etc.
- Handle the BE studies: print and send them to expert, archive them
- Surveillance of the official websites (WHO-PQ, USFDA, Eudra GMP, etc.) on pharmaceutical information, recall, variation or any new facts
Administrative support :
- Organize meeting when requested:
- Book the room, send the invitations to participants, update the lists of participants…
- Take minutes of meeting when requested
- Support to IPC (international pharmacist coordinator):
- In follow up of human resources (pharmacist contact list, holiday overview, sharing of information about pharmacist country visits)
- Organize pharmaceutical mailing lists: google groups (MSF international and IMES) as well as access rights to document repositories
- Follow-up yearly subscriptions (US Pharmacopeia, BP Pharmacopeia) and update pharmaceutical reference list regularly
- Distribution of pharmaceutical data and documents within the MSF pharmaceutical network
- Review the pharmaceutical folders in document repositories and support the IPC in maintaining and updating in document repositories folders
- Administrative support to translation when needed
- Can be the administrative back-up in case of absence
- Travel arrangement, hotel booking and logistics support to the three (3) QA coordinators and to external experts
- Undertake other duties as required
- Humanitarian interest
- English and French read, written, spoken - Very good English writing skills
- Experienced in database management
- Experienced in Quality System Management
- Experience in pharmaceutical environment a plus
- Knowledge of medical/public health matters, preferably in a humanitarian / development environment.
- Previous experience in similar position
- Software skills: Word, Power Point, Excel
- Able to work with the necessary precision and rigor requested
- Flexibility, availability, ability to travel
Starting date: September 2015
Contract: long term 100%
Application closing date: 15 August 2015
Please submit all applications only by email to: IOemail@example.com stating “Assistant to QA Coordinators” 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.