Consultancy in Rwanda
Lead Consultant: Medical Product Quality Assurance
Scope of Work
PQM+ is currently recruiting a consultant, based in Kigali, Rwanda to lead and support the day-to-day implementation of USAID-funded PQM+ Rwanda workplan activities for the benefit of Rwanda’s health system, the Rwanda Food and Drugs Authority (FDA) and the national medicines Quality Control laboratory of the Rwanda FDA. The consultant will work collaboratively with PQM+ staff and other consultants under the overall guidance of the PQM + Director for Eastern and Southern Africa.
The main scope of the work includes, but is not limited to, providing technical advice towards strengthening: post-marketing surveillance (PMS) of the quality of medicines in Rwanda; the testing capacity of the Rwanda FDA’s Drug Quality Control (QC) Laboratory; quality-assurance systems of local manufacturers of essential medical products; quality- assurance manuals, policies and guidelines of the Rwanda Medical Supply Limited (RMS LTD); and collaborating with the University of Rwanda to introduce course modules on quality assurance of medical products for pre-service and in-service training of health workers.
Importantly and with great urgency, the consultant will work with PQM+ team members to assist Rwanda FDA to implement relevant actions listed in the institutional development plan (IDP) of the authority, to assist the Rwanda FDA attain the WHO-Global Benchmarking Tool (WHO-GBT) Maturity Level 3, within the earliest possible time. This may include: assisting the QC lab to conduct proficiency testing (PT) and performance verification; to develop, revise, and update key Quality Management System (QMS) documents; to strengthen internal capacity for compendial testing techniques; facilitate the calibration and qualification of laboratory equipment to ensure measurements are accurate and reliable; to support implementation of ISO 9001, 17025:2017 and 19011 standards; and to support training and capacity building of the Rwanda FDA staff in QA and post-market surveillance.
Key Responsibilities
· Implements PQM+ technical activities under the guidance of the regional and US Rockville-based technical teams.
· Leads and manages other PQM+ local consultants in Rwanda.
· Collects and reports program data and indicators; documents and translates program information; and helps in coordinating in-country program logistics for implementation of workplan activities.
· Supports development of country work plans and budgets.
· Performs other duties as assigned by the program manager.
Deliverables
Qualifications and Experience
· Bachelor’s degree in pharmaceutical sciences.
· Master’s degree in pharmaceutical sciences/pharmaceutical quality assurance and quality control of medicines preferred.
· Post-qualification training in ISO 17025-based QMS, preferred.
· 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.
· Proficiency in compendial techniques for quality control testing such as HPLC, UV-Vis, Dissolution, Uniformity of Dosage Unit, FTIR, LOD, Disintegration test amongst several others.
· Strong communication skills and fluent in spoken and written English language.
· Fluency in English language is required.
· Ability to build relationships and interact effectively with technical experts, other partners, and donor agencies.
· Experience working with USAID projects preferred.
· Results driven with demonstrated successful outcomes.
· Must possess ability to work independently and handle multiple priorities in a fast-paced environment.
· Experience in implementation of ISO 17025:2017 based QMS (Internal auditing-ISO 19011, QMS development, CAPA management etc).
· Skills in training and workshop facilitation desired.
· Ability to demonstrate the highest degree of ethics and integrity.
· Excellent interpersonal and organizational skills with strong attention to detail.
IMPORTANT Note: This opportunity is only available to Rwandan nationals or holders of work permits and permanent residence permits for Rwanda.
Period of Performance
The anticipated period of performance is May 15, 2021 – December 31, 2021. Renewable depending on availability of country funding and satisfactory work performance by the consultant. In compliance with Rwanda labor laws, the consultant will be eligible to transition to a full-time position, after 6 months of continuous service.
This position is for Rwanda-based candidates only. No relocation assistance will be provided.
Please send CV, 3-References, and Hourly Rate to ATTN: Pascal Echeverri, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of May 10 ,2021
When submitting your application, write “Lead Consultant - Rwanda Medical Product Quality Assurance” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. In 2019, USP was awarded the Promoting the Quality of Medicines Plus (PQM+) program, a 5-year USAID-funded global program designed to sustainably strengthen medical product quality assurance (QA) systems in low-and-middle income countries. The main objectives of PQM+ program include: to improve governance of medical product QA systems, improve country and regional regulatory QA systems, optimize, and increase financial resources for QA, increase supply (manufacture) of quality-assured essential medicines and advance global learning and operational agenda, for medical products quality assurance.
