Expert in Medicines Quality Control/Laboratory Systems Strengthening for the Rwanda FDA
Scope of Work
PQM+ is currently seeking the services of an expert to be based in Kigali, Rwanda to lead and support the day-to-day implementation of USAID-funded PQM+ Rwanda workplan activities for the benefit of the Quality Control Laboratory (QCL) of the Rwanda Food and Drugs Authority (FDA). The consultant will work collaboratively with PQM+ staff and other consultants under the overall guidance of the PQM + Chief of Party in Rwanda.
The main scope of the work includes, but is not limited to, providing technical advice towards strengthening, policies, procedures, and operations of the Quality Control Laboratory (QCL) to fulfill the requirements for WHO prequalification and ISO/IEC 17025 accreditation. S/He will work with the QCL team to achieve the goals of the laboratory systems improvement, including achieving and sustaining the highest standards of laboratory quality management systems. The expert will be based in the laboratory and will provide hands-on technical assistance for strengthening the QCL quality system and good laboratory practices to meet the requirements for accreditation to current ISO/IEC 17025 standards, WHO prequalification and WHO GBT tool requirements
The expert should possess skills in quality control testing methods and techniques and compliance requirements of quality control laboratories. He/she must demonstrate understanding of the functioning of medicines testing laboratories that lead to ensuring that tested samples meet the set standards of quality, safety, and efficacy. The expert will guide QCL in setting and implementing internal and external quality requirements for quality testing of pharmaceuticals. This may include assisting the QC laboratory to participate in proficiency testing (PT) schemes and performance verification, to developing, revising, and updating key Quality Management System (QMS) documents, to strengthening internal capacity for compendial testing techniques and manufacturer methods, facilitating the calibration and qualification of laboratory equipment to ensure that measurements are accurate and reliable. He/she will help the QCL management 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 expert will work with other PQM+ team members to assist Rwanda FDA to implement relevant actions to assist the Rwanda FDA achieve compliance to ISO/IEC 17025, WHO prequalification, WHO GBT tool and other related quality standards.
Roles and Responsibilities
• Provide technical assistance in line with the PQM+ planned activities to support the Rwanda FDA’s medical products Quality Control (QC) laboratory.
• Work closely with the Rwanda FDA QCL to support development and deployment of QC laboratory-related strategies towards improvement of national regulatory systems.
• Work on the roadmap and action plan for QCL towards ISO/IEC 17025 accreditation and WHO prequalification attainment and strengthening of QCL ML3 status.
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports. Assist in the implementation of technical QA/QC activities of PQM+ by helping in technical trainings in laboratory quality management systems, instrumental techniques, and good documentation practices.
• Coordinate with the QMS Divisional Manager to map and consolidate the process for the various technical and management activities.
• To assess the readiness of the laboratory and initiate the WHO-prequalification process, to prepare a costed action plan and the budget for its further WHO pre-qualification.
• Support the laboratory with alignment of various technical and management documents i.e., Quality Manual, Standard Operating Procedures, Standard Testing Procedures, Work Instructions, Information Management Forms and Formats and Master lists of documents and equipment to ISO/IEC 17025:2017 standard, WHO GPPQCL guidelines and WHO GBT requirements
• Facilitate improvement of QCL’s inventory management system, data management system, laboratory safety, warehousing of chemicals, reference standards and samples among others.
• Provide updates on the laboratory activities in monthly/ quarterly reports.
• Assist QMS Divisional Manager to prepare QCL for ISO/IEC 17025 accreditation, and WHO prequalification through support in planned Mock Audits, Internal Assessments, CAPA plans, preparation of expression of interest and laboratory information files to be submitted for ISO/IEC 17025 accreditation and WHO prequalification.
• Assist Rwanda FDA to implement the QC laboratory-related aspects of relevant ISO family of standards.
• 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.
Required profile for job:
Basic qualifications
• Bachelor’s degree in chemistry/ Biochemistry/ Pharmacy/Pharmaceutical Sciences with at least 7 years of experience in pharmaceutical analysis of which 3 years’ being hands-on experience working in a national medicines quality control laboratory which has been both WHO prequalified and ISO/IEC 17025 accredited.
• Master’s degree with 5 years of relevant QA/QC experience in a pharmaceutical, or in analytical chemistry or in pharmaceutical technology, biotech
Preferred Qualifications
• At least 7 years’ experience in compendial, manufacturing and/or regulatory laboratories, with at least 3 years as a Senior Laboratory Analyst or laboratory Supervisor.
• Extensive working knowledge of pharmaceutical analytical methods and procedures, operation of analytical instruments, such as HPLC, HPTLC, Dissolution apparatus, UV-Vis, Titrators, Karl fisher, GC (MS or FID) or headspace should be added advantage), FTIR for testing of parenteral formulations, tablets, oral suspensions/oral solutions, creams, ointments etc.
• Proficiency and practical experience in laboratory equipment, process and system validations, including development and implementation of validation master plans, protocols and report writing.
• At least five-year experience in QMS environment such as ISO/IEC 17025 accredited and/or WHO prequalified laboratory and exposure to laboratory software.
• Experience in audits/inspections/assessments of quality control laboratories for quality management system implementation according to ISO/IEC 17025, ISO 9001, WHO PQ and WHO GBT tool.
• Experience in a similar work of consultancy in above assignment either in NRA-NCL or pharmaceutical industry with the scope of compendial testing would be a great advantage but not a requirement.
Skills Sought
• Expert level understanding and implementation of the WHO GBT tool, WHO prequalification process with focus on techniques, and ISO/IEC 17025 and ISO 9001 quality management systems
• Experience as an ISO/IEC 17025 accreditation technical signatory (TS) in at least two of the following techniques HPLC, UV-VIS, LOD, PH testing, Dissolution testing, Uniformity of Content etc
• Experience as an QMS internal auditor for ISO/IEC 17025 accreditation and/or ISO 9001 certification processes
• Development and implementation of validation plans and protocols for equipment, processes and computer systems.
• Development and implementation of competence mapping process for laboratory analysts
• Experience of working with regional regulatory bodies
• Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Skill to anticipate, troubleshoot, and solve technical problems.
• 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.
• Results driven with demonstrated successful outcomes.
• Must possess ability to work independently and handle multiple priorities in a fast-paced environment.
• Skills in training and workshop facilitation a must.
• Ability to demonstrate the highest degree of ethics and integrity.
• Excellent interpersonal and organizational skills with strong attention to detail.
Deliverables
• An inception report describing the key strategies, approach, methodologies, and plans/budgets for achievement of the assignment output.
• Technical reports or documents when applicable as in the approved PQM+ work plans.
• Report from the external audit conducted in the QCL, including observations made with references to WHO GPPQCL and ISO/IEC 17025 requirements.
• Report on millstones of the road map towards attaining ISO/IEC 17025 accreditation and WHO prequalification of the QC laboratory.
• Revised Standard operating procedures, standard testing procedures, quality manual, forms, register, work instructions and other QMS documents.
• Qualification of analytical equipment (calibration and verification) and computer systems validation.
• Implementation plan and report (activities, budget, and timelines for each activity) of corrective actions agreed and preventive actions with the laboratory for identified nonconformities related to ISO/IEC 17025 accreditation and WHO PQ requirements.
• Meeting notes and reports for all PQM+ represented meetings with the Rwanda FDA.
• Weekly activity summaries detailed monthly activity reports and monthly deliverables as assigned, which are required for consultancy payments.
• Report on hands-on training conducted for QCL staff in testing activities.
• Other relevant deliverables as requested by supervisors.
Documents to be included when submitting.
• Curriculum Vitae with proof of extensive working experience in ISO/IEC 17025 accredited and/or WHO prequalified NRA-NCL and 3 references from NRA QCL institutions or where similar work consultancy service was offered.
• Certificates of training in the required field: analysis of medicines (API&FPP), analysis of impurities in pharmaceutical formulation, validation/verification of analytical method, Quality management System (QMS), laboratory safety, audit of management system from a recognized body
• Certificates of training in major analytical equipment used in medicine testing such as HPLC (with DAD or FLD OR RID) detector, GC (FID OR MSMS) detector, LC MSMS, HPTL, FTIR, Dissolution, UV-VIS spectrophotometer, ICP (OES OR MS) detector
• Proof of successful participation in Proficiency Testing schemes
• Proof of skills in laboratory maintenance of analytical equipment
• Proof of QMS internal auditor qualification (ISO/IEC 17025 or ISO 9001)
• Proof of ISO/IEC 17025 accreditation technical signatory status
• Plan for the execution of this consultancy work with time schedule based on Duties and Responsibilities for Expert
IMPORTANT Note: This opportunity is available to both local and international experts. If an international expert is selected, he or she will be requested to apply for visa and work permits, or permanent residence permits for Rwanda.
Period of Performance
The anticipated period of performance is March 1, 2025 – April 30, 2025.
Evaluation
The individual consultants will be evaluated based on the cumulative analysis methodology. The award of the contract will be made to the individual consultant whose offer has been evaluated and determined as:
a) Responsive/compliant/acceptable
b) Having received the highest score out of the set of weighted technical and financial criteria specific to the solicitation
The criteria for the technical evaluation of the assignment shall be as follows:
# Criteria Rating/marks
1 Academic qualifications and other professional certificates as detailed in the terms of reference under consultant profile 20
2 The technical approach, work plan showing tasks timelines and other relevant factors pertaining to the provision of the services 30
3 Updated and signed CV with proven experience as specified in the terms of reference under consultant profile. 50
Applications
Please send CV, 3-References, and Hourly Rate to Pascal Echeverri, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of December 30, 2024.
When submitting your application, write “Rwanda Quality Control Laboratory (QCL) Consultant” 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 is an independent nonprofit organization with nearly 200 years of experience developing quality standards for medicines. Through its global public health programs, USP strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come. Through these efforts, USP is able to help detect and identify poor quality health products in disease areas such as HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as helping safeguard the maternal, newborn, and child health sectors.
USP was awarded the Promoting the Quality of Medicines Plus (PQM+) program, a USAID-funded global program designed to sustainably strengthen medical product quality assurance systems in low-and-middle income countries.
