Vacancy Announcement Long Term Technical Assistance Consultant US Pharmacopeia

About the job
Long Term Technical Assistance- Health Product Quality Assurance

Background:

The Promoting the Quality of Medicines Plus (PQM+) program is a U.S. Agency for International Development (USAID)-funded cooperative agreement that seeks to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to build in-country capacity of medicines regulatory authorities and quality assurance systems in assisted countries. PQM+ Nepal provides technical assistance to Department of Drug Administration, the National Medicines Laboratory, and local medicine manufacturers (both public and private manufacturers) and helps build awareness of the threat of SF medical products.

Objective:

The overall objective of this program is to strengthen medical product quality assurance (QA) and quality control (QC) systems in Nepal. PQM+ will provide technical assistance to the federal and provincial Health Product Regulatory Authorities, as they evolve, the government drug testing laboratories and its corresponding entities at the provincial level, private medicines testing laboratories, and local medicine manufacturers (both public and private allopathic; and ayurvedic manufacturers) and will help build awareness of the threat of SF medical products.

To support the planned and ongoing technical activities, PQM+ Nepal is seeking an international technical expert who can correlate the in-country technical activities with relevant international practices, bridge the knowledge of international experience in Nepal and maneuver the technical strategies of PQM+ in Nepal.

Scope of work:

Long term technical assistance will technically support PQM+ Nepal team in coordination with regional director, deputy chief of party, technical advisors and in collaboration with regulatory authorities and Laboratory staff to improve the efficiency of health product quality assurance and quality control through strengthening their processes and systems.

Assist Chief of Party of PQM+ Nepal to support the technical activities as per work plan.
Coordinate with in-country DCoP and Technical Advisors to strengthen quality assurance and control systems at the Department of Drug Administration, National Medicine Laboratory, local medicine manufacturers (both public and private allopathic manufacturers).
Drafting risk-based inspection guidelines/manual.
Draft Training curriculum on risk-based inspection including agenda, pre- and post-test assessment tools, session plan and slides, facilitators guide, participants guide etc.
Draft training curriculum on risk-based PMS with agenda, pre- and post-test assessment tools, session plan and slides, facilitator guide, participants guide etc.
Provide technical assistance to draft and finalize legal framework to regulate medicine, cosmetics, health technological products and nutraceuticals in Nepal.
Support technical team on providing technical overview on prequalification of priority essential MNCH products as per the corrective and preventive action (CAPA) plan generated after assessment of the industries.

Deliverables:

Final Draft manual of Risk based inspection guidelines/manual
Training curriculum on risk-based inspection (including Agenda, Pre and Post-test assessment tools, session plan and slides, facilitators guide, participants guide)
Training curriculum on risk-based PMS with agenda, pre- and post-test assessment tools, session plan and slides, facilitator guide, participants guide.
Final report at the end of consultancy

Basic Qualifications

Master’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
At least 10 years of experience in regulatory inspection for implementation of Good Manufacturing Practices (GDP), Good Distribution Practices (GDP), Good Storage Practices (GSP), and good laboratory practices (GLP) norms in related fields.
Experienced on WHO prequalification process for MNCH and FP products.
Detailed experience and knowledge about regulation and manufacturing of HTP
In depth knowledge about WHO, ICH and PIC/S guidelines on quality risk management and risk-based approaches.

Timeline

1 December 2021 – 31 July 2022

The consultant/Technical Assistant is expected to work approximately 3 – 6 months between December 2021 – July 2022 period.

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 November 28, 2022 when submitting your application, write “Long Term Technical Assistance Consultant” in the email Subject Line.