Consultancy in Quality Assurance for Medical Devices


Location : Home Based
Application Deadline :07-Apr-20 (Midnight New York, USA)
Type of Contract :Individual Contract
Post Level :International Consultant
Languages Required :
English   French  
Starting Date :
(date when the selected candidate is expected to start)
10-Apr-2020
Duration of Initial Contract :60 days
Expected Duration of Assignment :60 days

Background

The United Nations Development Programme (UNDP) is the UN’s global development network, advocating for change and connecting countries to knowledge, experience and resources to help people build a better life, as envisaged by 2030 Agenda for Sustainable Development. We are on the ground in more than 170 countries and territories, working with governments and people on their own solutions to global and national development challenges. As they develop local capacity, they draw on the people of UNDP and our wide range of partners that can bring about results.

UNDP’s partnership with the Global Fund is a powerful contributor to the 2030 Agenda for Sustainable Development including SDG 3 and UNDP’s Strategic Plan (2018-2021); through this partnership, UNDP plays a key role in supporting countries facing challenging circumstances to deliver the SDGs, to strengthen institutions to progressively deliver universal access to basic services (Outcome 3) and a return to sustainable development pathways in post conflict and post-disaster settings (Outcome 6). In strategic terms, in 2016 and 2017 the partnership between UNDP and the Global Fund was marked by increased convergence among implementation support, capacity development/systems strengthening and policy.

First, UNDP continued to strengthen its status as a key implementer of Global Fund grants in crisis and early recovery environments. Second, UNDP responded to increasing demand for capacity development from national entities and the Global Fund to strengthen resilient systems for health through a new generation of capacity development plans.  And third, as UNDP’s policy and implementation roles increasingly converge and reinforce each other, UNDP is supporting the Global Fund to increase engagement on human rights, key populations and gender aspects of disease responses at a strategic, policy and program level (as priority objectives in the Global Fund Strategy, “Investing to End Epidemics” (2017-2022). As of January 2017, UNDP served as the temporary Principal Recipient (PR) for 34 Global Fund grants covering 19 countries and 3 regional grants.  Given the importance of the partnership with the Global Fund, UNDP continues to provide high value-added services both in its PR role, increasingly as a significant technical partner to governments, and to civil society organizations (CSOs) who implement Global Fund grants. This is overseen by the BBPS/HHD Global Fund/Health Implementation Support Team (GF/HIST) in close coordination with Country Offices, Regional Bureaus, the Legal Office and the Bureau of Management.

 

UNDP’s Support to COVID-19

COVID-19 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.

Urgently and effectively addressing COVID-19 is critical to safeguarding progress on the SDGs. Through its presence in 140 countries and its integrator role, UNDP together with UN and other partners can support countries to immediately scale up evidence- and rights-based multisectoral responses, i.e. whole-of-government/whole-of-society responses, needed to effectively tackle COVID-19. In so doing, the organization can rapidly leverage its extensive presence and networks at global, regional and country levels, its mandate to work broadly – to connect the dots – across humanitarian and development sectors.

UNDP’s offer to countries is to support an equitable, inclusive and multi-sectoral response. UNDP support focuses on ensuring that crisis management and recovery responses to COVID-19 are leaving no-one behind, as part of a wider and coordinated UN response in supporting countries to implement the WHO Strategic Preparedness Response Plan (SPRP).   

The national and international health landscapes are rapidly changing: new health initiatives are emerging and bring to light pressing challenges connected with health systems strengthening including, health procurement and supply management that require a new modus operandi to optimize UNDP’s investments into global health. These opportunities go beyond UNDP’s partnership with the Global Fund.  In addition, there is a need for UNDP to continue to expand opportunities for partnerships with key stakeholders on health procurement including GAVI, World Bank and UNITAID. UNDP has a broad range of partnerships including with technical partners (e.g., WHO, UNICEF, UNFPA, Stop TB) and emergency and humanitarian partners (e.g., UNHCR, IRC, OCHA). 

Objective of the assignment

The consultant will assist UNDP GH-HIST team in the implementation and the monitoring of UNDP Quality Assurance Policy for Medical Devices (MDs). The Consultant expected to assess the sources (products) and the suppliers of medical devices and to contribute to the reinforcement of the capacity of UNDP staff to qualify MDs of appropriate quality. In addition, the Consultant will be supporting TASK Team 1 health system support, specifically UNDP’s response to COVID-19.

Successful candidates will also be invited to join the Health Procurement and Supply Chain Management Roster, which is a part of the GPN/ExpRes Deployment Mechanism.


Duties and Responsibilities

Under the overall supervision of the GF HIST Senior Health PSM advisor and the direct supervision of the Quality Assurance Specialist, the Consultant will provide assistance to the Quality Assurance Specialist for the implementation of the UNDP Quality Assurance  Policy and the validation of sources for procurement of medical devices (MDs) to include COVID-19. 

 The Consultant will: 

  1. Participate to the in-situ assessment of the procurement agencies based on WHO MQAS guidelines;
  2. Provide support to UNDP for the development of appropriate specifications for key MDs to include COVID-19;
  3. Assist in the updating UNDP’s Quality Assurance Manual with a focus on MDs to include COVID-19;
  4. Develop training modules “QA for Medical Devices”;
  5. Train UNDP GF HIST PSM and PSU/GPU staff (Geneva and Copenhagen) in QA for Medical Devices;
  6. When necessary, provide support in the preparation of Expression of Interest documents and Quality Assurance aspects in tendering documentation and assessment of offers/applications with a focus on MDs to include COVID-19.

Expected Deliverables: 

  • Reports reflecting the outcome of the in-situ assessments of Procurement Agencies;
  • Provide inputs for the chapters of the QA manual dedicated to MDs including COVID 19 and develop appropriate tools (questionnaire, assessment tools, checklists, etc.);
  • Develop modules in PPT format for the training on QA for MDs;
  • Recommend specifications for key MDs to include COVID-19. 

Reporting: The consultant will report to the GF HIST Quality Assurance Specialist. 

Travel:

The consultant will be home-based and when conditions allow may be requested to travel to Geneva, Copenhagen and places where the UNDP suppliers are based (one in USA and potentially one in Europe). The latter will be determined based upon a common agreement between UNDP and the individual consultant.

All travel costs (GVA and CPH) will be covered by UNDP according to its rules and regulations.  Travel, payment of travel costs including tickets, lodging and terminal expenses will be agreed upon, between UNDP and the Individual Consultant, prior to travel and will be covered and paid by UNDP. The fare will always be “most direct, most economical” and any difference in price with the preferred route will be paid for by the expert. 

Evaluation:

Applicants will be evaluated based upon their submitted expressions of interest and financial proposals, which includes a cumulative analysis method based upon a combination of technical and financial evaluation results.


Competencies

Functional Competencies:

  • Strong communication skills, including ability to produce high quality practical advisory reports and knowledge products, 

Project and Resource Management:

  • Ability to work independently, produce high quality outputs.   

Partnership building and team work:

  • Demonstrated flexibility to excel in a multi-cultural environment.
  • Provides constructive coaching and feedback. 

Communications and Advocacy:

  • Strong ability to write clearly, adapting style and content to different audiences and speak clearly and convincingly.
  • Strong presentation skills in meetings with the ability to adapt for different audiences.
  • Strong capacity to communicate clearly and quickly.
  • Strong inter-personal, negotiation and liaison skills


Required Skills and Experience

Required:

  1. Pharmacist or equivalent biomedical background with at least 10 years’ experience in the qualification.
  2.  Experience in the procurement of medical devices for health facilities located in GHTF founding member countries with at least 5 years’ experience with UN organizations or international NGOs.
  3. Good knowledge of WHO norms and standards for MDs and international regulations (IMDRF, GHTF, EU).
  4. Minimum of five (5) years of experience working with UN agencies and/or international NGOs.

An Asset:

Another UN language.

Guidelines for Applications:

Interested applicants are advised to carefully review this advertisement and ensure that they meet the requirements and qualifications described.

Applicants are to submit:

*Please note that the financial proposal is all-inclusive and shall take into account various expenses incurred by the consultant/contractor during the contract period (e.g. rent of dwelling, fee, health insurance, vaccination, visa costs and any other relevant expenses related to the performance of services...). All envisaged costs (except of the unforeseen travel costs for missions, if any) must be included in the financial proposal. Unforeseen travel costs for missions, if any, will be paid separately according to UNDP rules and regulations. All envisaged travel costs must be included in the financial proposal. Per diems cannot exceed UN DSA rates (http://icsc.un.org/rootindex.asp).

Security: Individual Consultants are responsible for ensuring 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

Incomplete applications will not be considered. Please make sure you have provided all requested materials.

Due to large number of applications we receive, we are able to inform only the successful candidates about the outcome or status of the selection process.


UNDP is committed to achieving workforce diversity in terms of gender, nationality and culture. Individuals from minority groups, indigenous groups and persons with disabilities are equally encouraged to apply. All applications will be treated with the strictest confidence.

UNDP does not tolerate sexual exploitation and abuse, any kind of harassment, including sexual harassment, and discrimination. All selected candidates will, therefore, undergo rigorous reference and background checks.


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