Quality Management System Consultant.

Statement of Work

Date: 16 September 2021

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

Title/Area: Recruitment of a consultant to provide technical support for the implementation of a quality management system (QMS) at the Department of Drug Administration (DDA) with the objective of having the DDA certified with ISO 9001:2015.

Title: Consultant– QMS

Estimated Period of Performance: 1st October 2021 to 14th July 2022

Total Level of Effort (LOE): 45 days

Introduction and Background:

Funded by the U.S. Agency for International Development (USAID), the MTaPS Program, implemented by Management Sciences for Health, provides pharmaceutical system strengthening assistance for sustained improvements in health system performance and to advance USAID’S goals of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, and combating infectious disease threats, as well as expanding essential health coverage. 

The goal of the global, five-year (2018–2023) program is to enable 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 medicine-related pharmaceutical services. To achieve this goal, the MTaPS program has the following objectives:

• pharmaceutical sector governance strengthened
• institutional and human resource capacity for pharmaceutical management and services increased, including regulation of medical products
• availability and use of pharmaceutical information for decision making increased and global learning agenda advanced
• pharmaceutical sector financing, including resource allocation and use, optimized
• pharmaceutical services, including product availability and patient-centered care to achieve desired health outcomes, improved

The DDA is the national medicine regulatory agency of Nepal established as per the Drugs Act 1978 and is one of the departments of the Ministry of Health and Population. The Act also provides the DDA a mandate to carry out its regulatory functions. DDA has 75 staff working in its central office in Kathmandu and three branch offices in Biratnagar, Birgunj and Nepalgunj. Since early 2020, MTaPS Program has been supporting the DDA to increase its maturity level as per the World Health Organization global benchmarking tool.

A functional QMS based on the ISO 9001: 2015 guidelines contribute to increase the capacity of the DDA to provide pharmaceutical regulatory services that meet customer, applicable statutory and regulatory requirements with enhanced customer satisfaction. To date MTaPS has supported the DDA in conducting a gap analysis and prepare a roadmap to establish quality management system; establish a technical working group (TWG); capacitate the members of the TWG on the International Register of Certified Auditors (IRCA), UK approved ISO 9001: 2015 auditor training; establish a quality policy; and draft a quality manual and a document control system procedure.

Therefore, the purpose of this consultancy is to assist the DDA building on the progress made so far to establish a functional QMS and prepare the DDA to undergo ISO 9001: 2015 audits for certification aimed by July 15, 2022.

Description of Services to be provided

The consultant will gather knowledge of on the existing gaps and challenges to assist the DDA understanding and implementing ISO 9001: 2015 standards in the regulatory process carried out by the agency. S/he will facilitate the DDA identify, properly document and effectively control all organizational processes pertaining to QMS. S/he will also provide training, help develop and maintain an internal audit program, conduct pre-assessments, support the ISO 9001: 2015 certification and help the DDA operates towards continuous improvement.

The consultant will undertake the following activities:

1. Review of gap analysis reports, roadmap and relevant documents and hold discussions with the DDA leadership and QMS TWG to update the roadmap and implementation plan to ISO 9001: 2015 certification
2. Review QMS documents, including Working Procedure Directive (karyavidhidigdarshan) prepared and/or updated by the DDA and provide feedback on improvements to existing systems, processes and procedures. Work in liaison with the QMS TWG for capacity building of DDA staff through continuous training or other capacity building activities to implement recommended improvements
3. Support the QMS TWG prepare and execute internal audit programming and planning. Prepare and submit an internal audit report
4.  Carryout a preassessment to identify any shortcomings and help the DDA take appropriate corrective actions prior to certification audit. Prepare and submit a preassessment report. Support the DDA in the selection of an external auditor for certification and facilitate certification audits

Preferred Qualifications/Experiences

• Bachelor's degree in pharmacy, medicine, business administration or other health related field
• Registered/certified as ISO 9001:2015 lead auditor (ISO 9000) with the IRCA, UK
• Minimum of ten (10) years of experience working as an ISO 9001 consultant and/or auditor in Nepal or other country in the region
• Proven prior experience in national medicine regulatory agencies or other government agency preferred 
• Proven track record of assisting organizations attain ISO 9001: 2015 certifications
• Prior experience working with USAID-funded projects preferred
• Advanced skills in MS and Google suite of products is required
• Excellent written and verbal communication skills in English is required
• Ability to organize the work with minimum supervision
• Ability to prepare and review reports, SOPs, training materials, documents and presentations
• Ability to design and conduct knowledge and skill-building training and workshops related to quality management system

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

• An updated CV including three references
• Budget requirement and payment terms