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. Our mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP envisions a world in which all have access to high quality, safe, and beneficial medicines, and foods. USP approaches this vision with a sense of urgency and purpose, strengthened by its cadre of dedicated volunteers, members, and staff, and by working collaboratively with key stakeholders across the globe. As the world gets smaller and more connected, quality issues affect everyone. The foundation of quality we are building helps address these and other global health issues. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we are there working to protect the health of people all over the world.
The Promoting the Quality of Medicines Plus (PQM+) Program, a Cooperative Agreement between the United States Agency for International Development (USAID) and the United States Pharmacopeia (USP) is a five year (2019 - 2024), PQM+ improves access to quality-assured πpriority medicines and addresses the proliferation of poor-quality medical products in low and middle-income countries through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, we help create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as improve maternal, newborn, and child health.
USP - PQM+ Pakistan team would like to hire a biomedical engineer consultant who is specialists and help to develop advanced healthcare technologies. Such consultant will not only work to ensure uninterrupted access to quality-assured medical products during the COVID-19 pandemic and future public health but will also engage the local private sector to manufacture quality-assured Personal Protective Equipment (PPE– masks, gloves, full-body gowns, all-over suits, shoe covers, goggles, face shields, and head covers). Under the overall direction of PQM+ Chief of Party the entity/Individual will:
1. Formulate a list of essential equipment with specifications for COVID-related PPE testing.
2. Assess public sector lab capacity to perform quality and regulatory testing of COVID-related PPE.
3. Provide technical support to procure essential lab equipment and initial supplies for the Central Drugs Laboratory (CDL) Karachi to start performing quality testing of PPE.
4. Provide training to CDL Karachi staff on lab techniques for testing PPE.
5. Scoping/Mapping of PPE manufacturer and prepare expressions of interest (EOIs) and formulate a list of interested manufacturer.
6. Conduct preassessment of interested manufacturers.
7. Support assessment of PPE manufacturer of private sector ready to invest for achieving international standard.
8. Conduct gap assessments of the selected manufacturers.
9. Advise to manufacturer for step vise approach to achieve accreditation and achieve international PPE standards.
10. Prepare corrective and preventive action (CAPA) plans based on the gap assessments.
11. Periodically monitor implementation of the CAPA plans.
12. Re-assess the manufacturers’ readiness for an ISO 13485, pre-audit, and other equipment specific standards
13. Perform mock audit of manufacturers.
14. Prepare CAPA and help in final implementation of CAPA.
1. Goods received notes (GRNs) of essential PPE testing equipment and supplies.
2. Adopted list of national PPE standards in accordance with WHO/international.
3. Minutes of the consultative meeting.
4. Assist Selection of PPE manufacturers
5. CAPA implementation reports
6. Training reports and documentation
1. A bachelor’s degree in biomedical engineering or clinical/medical engineering or bioengineering or electrical/mechanical engineering or equivalent with at least five years of technical experience in biomedical engineering.
2. Demonstrated expertise of biomedical testing equipment, procurement process, development of technical specifications and maintenance management systems.
3. Knowledge of medical devices nomenclature systems and regulatory standards.
4. Demonstrated creative problem-solving skills apart from analytical, communication, and team-working skills.
5. Demonstrated experience in training management and mentoring staff and others.
6. Excellent oral and written communication skills in English; knowledge of the local language is desired.
PERIOD OF PERFORMANCE
The scope of the work defined herein should be implemented within the years 2020-2021 between the assignment will be for 11 months from the date of the sign of the contract.
Selected firm/ individual will develop and work remotely in consultation with the USP Pakistan team and travel Islamabad for delivering the scope of work. USP Pakistan may decide to change the locations (city), increase or decrease the number of deliverables. The consultant will be informed of such a change in advance.
Selected firm/ individual will report to the PQM+ Chief of Party.
1. Financial Proposal - 35%
2. Qualification and Education - 35%
3. Experience - 30%
pThe 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. Our mission is to improve global health throug ...Read More