Consultant - Inspection

Statement of Work

Date: 22 April 2021

Project Name: USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program

Area: Short term technical assistance to strengthen capacity of the Department of Drug Administration for inspection and pharmacy registration in Nepal

Title: Consultant - Inspection

Estimated Period of Performance:10 months: from May 2021 to February 2022

Background:

The goal of the global five-year USAID Medicines, Technologies and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) including other relevant implementing agencies to strengthen pharmaceutical systems including pharmaceutical sector governance, regulatory systems, pharmaceutical management information systems, and improve patient-centred pharmaceutical services and appropriate medicine use.

MSH is seeking a consultant in support of MTaPS’s program in Nepal.

Description of Services to be provided

The consultant, in close collaboration with the DDA, Ministry of Health and Population, MTaPS, and other relevant stakeholders, will support the DDA to strengthen inspection, pharmacy registration and development of the Pharmadex inspection module.

This will be achieved by building on progress made to ensure that adequate legal provisions, including regulations and guidelines required to define the regulatory framework are in place. The consultant will support and work closely with, and be based at, the DDA to implement agreed workplans and strategies and provide technical assistance. The work of the consultant will be managed by the MTaPS team in collaboration with the inspection division of DDA.

The consultant will assist in the updating of the regulatory framework, including drafting of regulations, guidelines, and standard operating procedures. The consultant will support the implementation of current modules/functions of Pharmadex, registration of pharmacies and the development of Pharmadex inspection module; assist in the implementation and training on revised good pharmacy practices (GPP) and good distribution practices (GDP) for wholesalers and the updated electronic inspection tools. The consultant will also support capacity building and knowledge transfer to MTaPS and DDA staff in Nepal.

The consultant will undertake the following activities:

• Assist in the implementation of the inspection strategic plan and work plan to strengthen GPP and GDP requirements
• Assist in the development of system requirement specifications for regulatory management information systems
• Assist in transitioning pharmacy registration data from existing information system to Pharmadex and ensure data quality
• Assist in the implementation and provision of training to DDA inspectors on the inspection module in Pharmadex and the inspection toolin private and public sectors
• Assist in drafting relevant guidelines and procedures (SOPs)
• Assist in the implementation of capacity building activities to strengthen GPP and GDP
• Assist in the management of the inspection reports and documentation. 
• The consultant will primarily be located at the DDA and follow DDA working hours.

Preferred Qualifications/Experiences

• Preferably a master’s in pharmacy degree holder who has working experience in community and/or hospital pharmacy or related field
• At least five years of relevant experience in areas of pharmaceuticals, medicines management, quality assurance, regulation and hands-on experience in regulatory systems
• Knowledge about functions of a medicine regulation/good knowledge of pharmacy, drugs, laws and regulations to be enforced
• Experience and expertise in management information systems and IT based tracking systems and in training g/capacity building,
• Excellent writing skills and experience in facilitation and motivation
• Specialized experience and knowledge of the registration of medical products and medicine management (quality assurance, good pharmacy practices & supply chain) as well as work experience with drug regulatory body is preferred
• Understanding of pharmaceutical legal and regulatory systems and situations in Nepal
• Ability to organize their own work with minimum supervision
• Ability to design and conduct knowledge and skill-building workshops and trainings
• Ability to write and prepare reports, training materials, documents and presentation
• Excellent written and verbal communication skills in English

The interested candidate possessing above qualification and experiences are requested to apply with the following details at npprocurement@msh.org

• An updated CV including three references