Technical Assistance to Strengthening Quality Management Systems (QMS) of Medicines Quality Control Laboratories in Central Asia
Scope of Work
The Promoting the Quality of Medicines Plus (PQM+) program is a five-year (September 27,2019 - September 26, 2024) U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in LMICs. USP seeks a Pharmaceutical Quality Control Laboratory Quality Management Systems consultant to provide support to PQM+ programs in Central Asia (Uzbekistan, Kazakhstan, and Tajikistan). The consultant should have expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. S/he will provide technical assistance based upon expertise and knowledge of evidence-based methods and strategies, current practice, and established laboratory and operational standards. S/he will work within a dynamic, fast-paced environment and is responsible for providing day-to-day technical program implementation support for a multi-project portfolio. S/he will liaise with donors, national counterparts, and USP staff, and consultants to provide technical support to PQM+ Central Asia projects, ensuring the development of high-quality project deliverables and compliance with all USP and donor requirements.
Key Responsibilities
· Work closely with the Director, Health Elements, Program Manager, and local staff to provide technical program implementation support for PQM+ Central Asia portfolio of projects.
· Conduct facility inspections to ensure environmental, equipment and staffing capabilities, which will be applied to corrective and preventive actions.
· Continuously evaluate the laboratory’s progress toward maintaining/obtaining the labs ISO 17025 certification and/or WHO prequalification.
· Help track data to support quality metric reports ensuring laboratory compliance and follow-up through continual improvement.
· Provide trainings to the staff of the laboratories in the specific areas as needs are identified (e.g., good laboratory practice, analytical methods).
· Assist in preparation of medicines quality control laboratories (MQCLs) for WHO inspections, including assistance in strengthening QMS procedures to prepare the labs for WHO inspections, conducting of mock audits and preparation of laboratory information files to be submitted to WHO.
· Assist the laboratories during WHO inspections, assist in development of CAPA plans after WHO’s PQ inspections, and support in their implementation.
· Timely preparation and submission of technical assessment and travel reports.
Deliverables
· Gap analyses report
· Training report
· Technical reports
· Trip reports
· Meeting notes
· SOPs, guidelines
· Others as applicable
Qualifications
· Bachelor’s Degree in science or equivalent years of education and/or relevant quality assurance experience in a pharmaceutical, biotech, or other regulated industry.
· Minimum of ten years QA experience and experience auditing QC labs, or a minimum of ten years of experience working in a QC laboratory.
· Pharmaceutical background and experience with QA/QC of pharmaceuticals required.
· Experience with Pharmaceutical microbiology QA/QC is a plus.
· Knowledge of analytical chemistry and QA/QC processes in the pharmaceutical industry required.
· Excellent understanding of ISO 17025 and WHO prequalification requirements.
· Demonstrated skill in audit planning and lead auditing techniques.
· Demonstrated experience in conducting trainings on Good Laboratory Practices (GLP) for the staff of medicines quality control laboratories.
· Ability to explain complex information in simplistic terms, to a diverse audience.
· Articulate, professional and able to communicate effectively with GPH staff and consultants and key internal and external stakeholders.
· Excellent writing skills including an ability to develop clear project documentation, reports, meeting notes, and written communications with internal and external stakeholders.
· Ability to work independently, as well as with cross-cultural and cross-functional teams.
· Willingness to travel to Central Asia.
· Advanced computer competence (e.g., MS Office).
· Knowledge of Russian is preferred.
· Previous experience working with programs aiming to strengthen medicines quality assurance systems is preferred.
· Previous experience working in the countries of Central Asia is preferred.
Period of Performance
October 1, 2022, to September 30, 2024
How to apply
· Please send your CV, 3-References, and Hourly Rate in US$ to ATTN: Masoud Azam, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of September 06, 2021 When submitting your application, write “QMS Consultant – Central Asia” 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 (LMICs) with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.
