Overview
Lead MSF Drug Quality Assurance activities to identify new quality sources of drug supply, consolidate the MSF drug QA system, and monitor international regulatory developments.
Key Responsibilities
- Coordinate and lead ESCs (QAs and buyers) in pharmaceutical aspects of source search, selection, and use of essential medicines.
- Coordinate with SPINCO and working groups for MSF catalogues and QA/supply checks for new medicines.
- Create and revise the MSF Quality Management System for medicines.
- Organize annual product dossier audits and manage CAPA following audits.
- Write the annual report of QA activities.
- Coordinate product qualification activities within the IPC team, including dossier assessment and approval.
- Maintain quality reviews in UniQuality for various approval routes.
- Manage external experts for therapeutic equivalence assessment.
- Perform risk assessments and prepare documentation for DirMeds decisions.
- Participate in manufacturing site audits and technical/monitoring visits.
- Brief and coach newcomers on MSF QMS, Qualification Scheme, and product dossier assessments.
- Provide technical guidance and support to ESCs pharmacists on QA and procurement.
- Act as MSF focal point for antimalarial medicines internally and externally.
- Participate in the work of the malaria contact group.
- Update technical information in UniQuality for anti-malaria medicines.
- Revise the list of priority medicines with working groups.
- Act as focal point with working groups on pharma-related issues.
- Contribute to the definition and implementation of the Pharma Network strategy and action plan.
- Contribute to Supply Transformational topics strategy.
- Guide ESCs to achieve a coordinated approach to access to quality medicines.
- Guide technical developments of the UniQuality tool.
- Liaise with WatSans for updated information on waste management.
- Support the IPC on specific requests or dossiers.
Required Experience
Minimum 5 years of experience. At least 2 years in MSF. Mandatory experience in quality assurance. Good knowledge of MSF quality and procurement policies.
Qualifications
Master's degree in Pharmacy