The U.S. Pharmacopeial Convention (USP) Senior Technical Officer PQMPlus in Kigali, Rwanda
Summary of the Position
The Senior Technical Officer, Quality Control/Laboratory Systems Strengthening (STO- QC/LSS) will have expert skills in quality testing methods and techniques and compliance requirements of national pharmaceutical quality control laboratories. He/she must demonstrate understanding of the functioning of drug testing laboratories that lead to ensuring that tested samples meet the set standards of quality, safety and efficacy. The selected STO will be a technical resource to the Rwanda Food and Drug Authority (FDA’s) Drug Quality Control (QC) laboratory and will guide it in setting and implementing internal and external quality requirements for quality testing. This may include assisting the QC lab to conduct proficiency testing (PT) and performance verification; to developing, revising, and updating key Quality Management System (QMS) documents; to strengthening internal capacity for compendial testing techniques; facilitating the calibration and qualification of laboratory equipment to ensuring measurements are accurate and reliable. He/she will help the lab to identify staff training requirements to meet the quality standards and develop and monitor corrective measures towards strengthening the technical capacity of the laboratory. The selected candidate will work with other PQM+ team members to assist Rwanda FDA to implement relevant actions listed in the institutional development plan (IDP) of the authority, focusing on the QC laboratory, to assist the Rwanda FDA attain the WHO-Global Benchmarking Tool (WHO-GBT) Maturity Level 3, and assist the QC laboratory to achieve ISO 17025 and other related quality standards. He/she will provide technical oversight of the QC related components of the PQM+’s objective of improving country and regional regulatory systems to assure the quality of medical products in the public and private sectors of Rwanda.
Roles and Responsibilities
• Provide technical assistance in line with the planned activities to support the Rwanda FDA’s drug Quality Control (QC) laboratory
• Assist Rwanda FDA to implement the QC laboratory-related aspects of the institutional development plan (IDP) to facilitate attainment of maturity level 3 and ISO standards
• Propose, design and implement interventions aimed at strengthening the QC laboratory systems including developing and implementing protocols, guidelines, procedures and other relevant tools
• Provide technical leadership and support to improve efficiency, effectiveness and sustainability of the QC laboratory
• Support building capacity of the QC laboratory in adoption and implementation of relevant testing methods and techniques
• Work closely with the Rwanda FDA to support development and deployment of QC laboratory-related strategies towards improvement of national regulatory systems
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
• Bachelor's degree in pharmacy, pharmaceutical science, chemistry or other science related field of study required
• Minimum of 8 + years of experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals
• At least 5 years’ hands-on experience working in a pharmaceutical quality control laboratory either within a pharmaceutical manufacturing company or a medicines regulatory authority
• Understanding of the WHO GBT tool and ISO quality assurance systems
• Direct experience implementing USAID-funded programs
• Experience of working with regional regulatory bodies
• Experience in implementation of ISO 17025:2017 based QMS (Internal auditing-ISO 19011, QMS development, CAPA management etc.)
• Experience in at least one of the following health areas: malaria, NTDs, MNCH, COVID-19
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The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Technical Programs
Job Type Full-Time