Global Call for UNDP ExpRes Roster/Health PSM Profile - GPN Roster Sub-profile Quality Assurance Experts (PHARMACEUTICALS)

Contract

This is a International Consultant contract. More about International Consultant contracts.

Background

UNDP is the knowledge frontier organization for sustainable development in the UN Development System and serves as the integrator for collective action to realize the Sustainable Development Goals (SDGs). UNDP's policy work carried out at HQ, Regional and Country Office levels, forms a contiguous spectrum of deep local knowledge to cutting-edge global perspectives and advocacy. In this context, UNDP invests in the Global Policy Network (GPN), a network of field-based and global technical expertise across a wide range of knowledge domains and in support of the signature solutions and organizational capabilities envisioned in the Strategic Plan.

Within the GPN, the Bureau for Policy and Programme Support (BPPS) has the responsibility for developing all relevant policy and guidance to support the results of UNDP's Strategic Plan. BPPS's staff provides technical advice to Country Offices, advocates for UNDP corporate messages, represents UNDP at multi-stakeholder fora including public-private dialogues, government and civil society dialogues, and engages in UN inter-agency coordination in specific thematic areas. BPPS works closely with UNDP's Crisis Bureau (CB) to support emergency and crisis response. BPPS ensures that issues of risk are fully integrated into UNDP's development programmes.

UNDP is a founding cosponsor of the Joint UN Programme on HIV/AIDS (UNAIDS), a partner of the Global Fund to Fight AIDS, TB and Malaria, and a co-sponsor of several other international health partnerships. UNDP’s work on HIV, health and development, as described in the HIV, Health and Development Strategy 2022-2025: Connecting the Dots, leverages UNDP’s core strengths and mandates in human development, governance and capacity development to complement the efforts of specialist health-focused UN agencies. UNDP delivers three types of support to countries in HIV, health and development.

First, UNDP helps countries to mainstream attention to HIV and health into action on gender, poverty and the broader effort to achieve and sustain the Sustainable Development Goals. Second. UNDP works with partners to address the interactions between governance, human rights and health responses. Sometimes this is done through focused or specialized programmes, such as promoting attention to the role of the law and legal environments in facilitating stronger HIV responses, including the use of flexibilities in intellectual property law to lower the cost of medicines and diagnostics.

Third, as a trusted, long-term partner with extensive operational experience, UNDP supports countries in effective implementation of complex, multilateral and multi-sectoral health and development projects, while simultaneously investing in capacity development so that national and local partners can assume these responsibilities over time.

UNDP’s Partnership with the Global Fund

UNDP’s partnership with the Global Fund is an important part of this work, facilitating access to resources for action on SDG 3 by countries that face constraints in directly receiving and managing such funding. UNDP partners with countries in crisis/post-crisis situations, those with weak institutional capacity or governance challenges, and countries under sanctions. When requested, UNDP acts as interim Principal Recipient (PR) in these settings, working with national partners and the Global Fund to improve management, implementation and oversight of Global Fund grants, while simultaneously developing national capacity to be able to assume the Principal Recipient role over time. Health product procurement and supply chain management support are an integral part of UNDP’s PR role and also providing development solutions and support services that UNDP provides for the implementation of large and complex health and development programmes. UNDP’s partnership with the Global Fund and other health partners (eg GAVI) is overseen by the Global Fund Partnership and Health Systems Team (GFPHST), HIV and Health Group, BPPS/GPN. The GFPPHIST provides its support to COs through a country team approach to strengthen and integrate the different functional capacities, leveraging technical assistance and policy support from the HIV and Health Group and other GPN teams and advisory services from the Office of Audit and Investigations (OAI).

The COVID-19 pandemic is a critical issue for UNDP. It is as much a health and development emergency as it is a human security crisis. In order to deliver on its mission eradicating poverty, reducing inequalities and building resilience to crisis and shocks, UNDP must help countries to urgently and effectively respond to COVID-19 in the context of the 2030 Agenda.

In line with established best practice, UNDP has a Quality Assurance for Health Products (QA) Policy for all health products supplied by UNDP. The UNDP QA Policy is a key document for all parties involved in health procurement activities across UNDP as well as for national partners, suppliers and donors as it details UNDP’s requirements for health procurement, which are in line with international best practice. Regular monitoring and oversight of the implementation of the QA policy, and support to its implementation, is under the responsibility of Global Fund Partnership Team.

In order to provide effective support to our partners worldwide, UNDP seeks Quality Assurance Experts with experience in the health sector to submit their applications for inclusion in the pre-approved GPN/ExpRes Roster. The GPN/ExpRes Roster is a recruitment and deployment mechanism which maintains technically vetted consultants across 21 profiles and 79 sub-profiles to support the work of UNDP Country Offices/units and other UNDP partner agencies. The qualified individuals based on competencies and value for money principle may be called upon to be contracted and deployed to provide specific technical advice and short-term assignments for periods, normally not to exceed 6 months.

To this effect, UNDP invites eligible and interested Quality Assurance experts with experience and expertise in the health sector, to submit their application in response to this Expression of Interest, to be included in the specialized roster category as defined below:

• Quality Assurance Expert in quality control, quality assurance, and pharmaceutical policy.

A screening procedure will be applied to select the prospective applicants to be registered in the Roster. Retention in the Roster of selected experts will be contingent on continuous delivery of satisfactory services

Duties and Responsibilities

The following is a generic and non-exhaustive list of tasks and functions, however a context-specific Terms of Reference (TORs) will be issued for each assignment.

Area of expertise

Brief Description of some Tasks

Quality Assurance Experts

Development and monitoring implementation of Quality assurance (QA) and Quality Control (QC) plans.

Development of training packages for UNDP’s Country Offices and develop and revise guidance materials, SOPs, and tools and support training activities for UNDP

• Develop guidance and SOPs for the Quality Assurance plans.
• Develop Quality Assurance plans for UNDP Country Offices
• Develop Quality Control plans for UNDP Country Offices.
• Review laboratory test reports and decides on acceptance of the products.

Travel: When travel is required to be undertaken to a UNDP location for a specific assignment, payment of travel costs including tickets (lowest economy class only), lodging and terminal expenses shall be covered by UNDP.

Competencies

Required skills and competencies

• Understanding of WHO guidelines on pharmaceutical procurement, regulations, storage, and distribution.
• Experience working in or supporting a national regulatory or procurement agency.

Desirable additional skills and competencies

• A good understanding of risk assessment of related to health products is an asset;
• Experience providing support to a UN Agency or International organization in quality assurance or quality control of health products (eg WHO, UNICEF, or USAID) is an asset;
• Experience in writing national drug policy is an asset;
• A good understanding of rational drug use is an asset;
• Fluency in French or Spanish or Russian or Portuguese is an asset.

Required Skills and Experience

• Quality Assurance Experts in quality control, quality assurance, and pharmaceutical policy

Min. Academic Education

• Masters' degree in pharmacy, pharmaceutical science, biochemistry, chemistry or biotechnology, or a related discipline

Min. years of relevant Work experience

• At least 7 years' experience in regulation or quality assurance in procurement or health product quality control or quality assurance in a manufacturing facility or in a quality control laboratory of health products.

• Working Arrangements

  • Candidates successfully selected through a technical criteria review will be included in the UNDP GPN/ExpRes Roster;
  • The level of work requirements will vary according to each individual assignment (including whether or not travel is required);
  • Experts will be home or office-based with possible mission travel, depending on the assignment;
  • UNDP does not warrant that any quantity of services will be purchased during the term of entry into the Roster as this will depend on forthcoming needs and performance appraisals;
  • Entry into the Roster is non-exclusive (i.e. it does not prohibit UNDP from sourcing expertise from other rosters, entities, or individuals).
  • The final nature and scope of each assignment will vary and will focus on particular aspects of this Terms of Reference (TOR). Such details will be included in a separate TOR for each specific assignment;
  • The financial proposal will specify only the all-inclusive daily fee and payments will be made to the consultant based on number of days worked payable against assigned deliverables. Such fee would be the ceiling amount.
  • The Expert will be responsible for providing her/his own working station (i.e. laptop, internet, phone, scanner/printer, software, etc.) and must have access to reliable internet connection;
  • Given the global consultations to be undertaken during his/her assignment, the Expert is expected to be reasonably flexible with his/her availability for such consultations taking into consideration different time zones where applicable;
  • Payments will be made as specified in the actual contract upon confirmation of UNDP on delivering on the contract obligations in a satisfactory manner and as per specified due dates.

  Procedures for submission of applications

  Interested individuals must submit the following documents to demonstrate their qualifications:

  1. Brief statement explaining the merits of the candidacy (1000 characters or less, to be uploaded directly to the system).

  2. A completed and uploaded Health PSM Roster application form with:

  • Selected categories with the total number of years and provided summary of relevant experience, and AT LEAST 3 supporting references (including name, email and phone number - see Health PSM Application Form, Section c, d, e.)
  • Financial proposal providing a quote for a daily professional rate in USD (See Health PSM Application Form, Section f)). Consultants shall note that the daily rate specified in their submission will be considered as a ceiling amount / maximum daily rate.
  • Completed P11 form (for service and Individual Contracts) section and the Health PSM Roster application duly signed and submitted.

  IMPORTANT: Please note that only 1 (one) file —the Health PSM Application Form— can be uploaded to the UNDP JOBS SYSTEM. Therefore, please submit this application form as one file into the system. The template corresponding to Health PSM Application Form can be found in this link: Health PSM Application Form

  The applications shall contain and include all information & documentation detailed above and will be assessed on a quarterly basis based upon the following schedule:

  Evaluation, selection criteria and process:

  Step One: Screening:

  The received applications shall be screened against the following criteria:

  • Qualifications
  • Required years of experience
  • Submission of filled in and signed application form attached.
  • Submission of P11 Form attached.
  • Fluency in English.

  Only applicants passing the screening stage shall be considered for further evaluation.

  Step Two: Evaluation:

  The evaluation of each application will be based on a set of selection criteria as listed in the below table and on the basis of the information submitted by each candidate. Only candidates fulfilling the minimum expertise, experience and qualifications required will be considered.

  Applicable Evaluation Criteria

  Points

  Education & Professional qualification

  Up to 14 points

  Relevant Experience

  Up to 80 points

  Language requirements

  Up to 6 points

  UNDP may conduct an interview round with applicants, prior to issuance of a final recommendation to include the applicant in the roster, for purpose of determining fulfilment of language and competencies related requirements.

  A review of the daily fees proposed by technically qualified experts will follow, to determine adherence to maximum allowed UNDP daily fees for experts. In cases where daily fees submitted by consultants exceed maximum allowed UNDP daily fees for each band, the consultant will be invited to review his/her quoted daily fee downwards accordingly.

  Monitoring and reporting arrangements upon assignment:

  • The Experts shall be supervised by an assigned GPN/BPPS/HHD/GF HIST Team QA focal point and s/he will report progress on a periodical basis for inputs and guidance.
  • Upon award of contract, the Expert should deliver a detailed work plan for the project, which will govern the reporting and monitoring aspects. The review and approval of payments will be made by the assigned supervisor(s) where the last tranche of payment can be only processed upon issuance of a performance evaluation.

  Other Information:

  Security: When travel is required all Experts must complete take the BSAFE mandatory security training and obtain security clearance to travel..

  Inoculation/Vaccinations: Individual Consultants are responsible for ensuring that they have vaccinations/inoculations when travelling to certain countries, as designated by the UN Medical Director. Consultants are also required to comply with the UN security directives set forth under https://trip.dss.un.org

  Statement of medical fitness for work: Individuals whose assignments require travel and who are over 65 years of age are required, at their own expense, to undergo a full medical examination, including x-rays, and obtain medical clearance from a UN-approved doctor prior to taking up their assignment. This does not apply to individuals engaged through a reimbursable loan agreement. The medial clearance is valid only for 12 months from date of issuance.