Background

UNDP is a key partner to the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (GF) and is the UN agency assuming the role of Principal Recipient (PR) of GF grants in Sudan. As the Principal Recipient of 5 grants (2005-2014) from the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (GFATM) amounting to USD 300 million,  UNDP is managing the largest fund portfolio in the Arab region. UNDP‘s management role consists in implementing grants, ensuring financial accountability, and training of a variety of national and international counterparts on programme management and financial accountability. In its role as Principal Recipient, UNDP ensures quality financial management, timely procurement of supplies and service delivery as well as efficient monitoring and evaluation of grant implementation activities.

UNDP has established a dedicated Project Management Unit (PMU) responsible for managing the GF grants. The PMU is seeking the services of a GMP specialist (IC) on a temporary stop-gap capacity support. The contractor will be stationed in Khartoum with some field supervision activities.

Duties and Responsibilities

Scope:

The objective of this exercise is to engage an Individual Contractor to help UNDP to enable the Government of Sudan, and specifically the National Medicines and Poisons Board (NMBP) in the regulation of the Quality Assurance Measures. This is part of the NMBP plans to develop and take sound and effective regulation and quality assurance measures to ensure the safety, effectiveness and quality of pharmaceutical products, medical devices and cosmetics, as needed, in order to protect and promote the health and wellbeing of the Sudanese people and to attain the strategic goals set by the state; using scientific approaches based on the principles of good governance and values of justice, transparency and partnership.

Based on the above, the assignment’s main objective will be to increase the capacity of NMPB Inspectors.

For detailed information, please refer to Annex 1- Terms of Reference.

Objectives of Engagement:

The objective of this exercise is to engage an Individual Contractor to help UNDP to enable the Government of Sudan, and specifically the National Medicines and Poisons Board (NMBP) in the regulation of the Quality Assurance Measures. This is part of the NMBP plans to develop and take sound and effective regulation and quality assurance measures to ensure the safety, effectiveness and quality of pharmaceutical products, medical devices and cosmetics, as needed, in order to protect and promote the health and wellbeing of the Sudanese people and to attain the strategic goals set by the state; using scientific approaches based on the principles of good governance and values of justice, transparency and partnership.

Based on the above, the assignment main objective will be to increase the capacity of NMPB Inspectors.

Proposed Subject:

  • Quality risk management;
  • HVAC System;
  • GMP of Sterile Pharmaceutical Products;
  • Validation;
  • Qualification of HAVC system & maintenance water system;
  • Qulaifications of systems & Equipment.

Expected  Output:

Conduct GMP training to 25 NMPB's Inspectors.

This deliverable will be considered successfully completed upon certification by the UNDP Supply Chain focal person.

Duration of the Assignment:

The Individual Contractor is expected to start the work tentatively as per the below details:

  • Travelling to Khartoum on 15th April 2015;
  • Preparation day 16th April 2015;
  • Training days 17, 18, 19, 20, 21, 22, 23, 24, 25, 26th April 2015;
  • Reporting day 27th April 2015;
  • Travelling back home on the 28th April 2015.

Competencies

Functional competencies:

  • Ability to work in context of diversity;
  • Creativity in conducting training sessions;
  • Skillful in managing participative training, facilitating focus group discussion and leading team work;
  • Up to date in the GMP issues and ability to communicated in the training, with the context of Sudan regulations in the GMP.
  • Excellent knowledge of Microsoft office;
  • Excellent Communication, Inter-personal and facilitation skills.

Corporate competencies:

  • Displays cultural, gender, religion, race, nationality and age sensitivity and adaptability;
  • Highest standards of integrity, discretion and loyalty.

Required Skills and Experience

Academic Qualifications:

  • A pharmacist with post graduate degree in industrial pharmacy or Quality assurance or related field;
  • Certificate in GMP, Quality Assurance and/or Quality Management;
  • Publication in GMP or other related field is an asset.

Experience:

  • 5 years of relevant experience in GMP training in public and/or private sector, non-governmental organization or international organization;
  • Minimum 5 years’ experience in industrial pharmacy;
  • Previous similar training experience in Sudan or similar context is an asset.

 Language:

  • Fluency in English is mandatory.