Consultancy Services for Technical Review of Reports

US Pharmacopeial Convention

Job Summary

Under the overall guidance and supervision of the PQM+ Director for Eastern and Southern Africa, coupled with specific technical guidance of the PQM+ technical team in Kenya and in Rockville, USA, the technical review consultant will undertake a detailed review of technical reports generated during implementation of the planned activities.

  • Minimum Qualification: Bachelor
  • Experience Level: Mid level
  • Experience Length: 5 years

Job Description/Requirements

Scope of Work

Consultancy Services for Technical Review of Reports

About USP and the PQM+ Program

The U.S. Pharmacopeial Convention (USP) is a scientific non-profit 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 takes a systems approach to strengthening pharmaceutical regulatory systems through donor funded programs.


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, including Kenya. PQM+ provides technical assistance to build in-country capacity of medical products regulatory authorities’ quality assurance systems spanning manufacturing, distribution and use in health systems. The program also provides technical support to manufacturers of malaria; tuberculosis (TB); neglected tropical diseases; other infectious diseases; family planning and reproductive health; and maternal, newborn, and child health.**


Brief Description of Purpose and Nature of the Assignment

PQM+ adopts a systems strengthening approach utilizing cross-sectoral approaches and the application of international quality assurance standards across the pharmaceutical system. The program heavily uses information and data to achieve its objectives. The PQM+ program seeks to provide leadership in creating resilient and robust local health systems by sharing scientific expertise and providing technical support and leadership. Information/knowledge sharing is therefore core to the work of the program.


In Kenya, USAID PQM+ program is working with the Pharmacy and Poisons Board (PPB), the National Quality Control Laboratory (NQCL), the Division of National Malaria Program (DNMP), the Department of Health Products, and Technologies (DHPT), Division of Family Health (DFH), the counties and pharmaceutical manufacturers and continues to collaborate with the institutions to achieve its objectives including supporting the local production of quality assured health products and technologies.


Under the overall guidance and supervision of the PQM+ Director for Eastern and Southern Africa, coupled with specific technical guidance of the PQM+ technical team in Kenya and in Rockville, USA, the technical review consultant will undertake a detailed review of technical reports generated during implementation of the planned activities.


Key responsibilities/Tasks

The selected consultant will

  1. Use domain knowledge to provide constructive feedback and undertake corrective measures.

  2. Ensure the approaches, methods and analysis are adequately detailed to enable comprehension of the reader.

  3. Ensure the report (s) is/are clear, concise, and relevant to the scientific value desired and within the objectives agreed.

  4. Ensure correct presentation of the report (s) e.g., citations, ethical considerations, logical flow.

Deliverables

  1. Report on regulation and manufacture of pharmaceuticals in Kenya.

  2. Report on assessment of select pharmaceutical manufacturers and the Pharmacy and Poisons Board.

Requirements

  1. Bachelor’s degree in Pharmacy or other health related course.

  2. Master’s in pharmacy or other related qualification.

  3. Proven experience in health research and reporting.

  4. Experience in scientific research writing and publication.

Time frame

The level of effort for the work is six (6) days to be conducted within December 2021.

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