Quality Assurance Specialist (Health Products)


Location : Home-based
Application Deadline :18-Nov-21 (Midnight New York, USA)
Type of Contract :IPSA (Regular)
Post Level :IPSA-11
Languages Required :
English  
Starting Date :
(date when the selected candidate is expected to start)
01-Oct-2021
Duration of Initial Contract :12 months

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.


Background

Instructions to Applicants: Click on the "Apply now" button. Input your information in the appropriate Sections: personal information, language proficiency, education, resume and motivation. Upon completion of the first page, please hit "submit application" tab at the end of the page. Please ensure that CV or P11 and the Cover letter are combined in one file.

The following documents shall be required from the applicants:

  1. Personal CV or P11, indicating all past positions held and their main underlying functions, their durations (month/year), the qualifications, as well as the contact details (email and telephone number) of the Candidate, and at least three (3) the most recent professional references of previous supervisors. References may also include peers.
  2. A cover letter (maximum length: 1 page) indicating why the candidate considers him-/herself to be suitable for the position.
  3. Managers may ask (ad hoc) for any other materials relevant to pre-assessing the relevance of their experience, such as  reports, presentations, publications, campaigns or other materials.

Travel:  Travel costs are covered only in the event that the function will be undertaken physically in the duty station and excludes working from home arrangements.The Contractor may also be expected to undertake duty travel associated with performing the functions.

Office/Unit/Project Description           

United Nations Development Programme (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 Hubs 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.  BPPS assists UNDP and partners to achieve higher quality development results through an integrated approach that links results-based management and performance monitoring with more effective and new ways of working.  BPPS supports UNDP and partners to be more innovative, knowledge and data driven including in its programme support efforts.

The 2030 Agenda for SDGs and the pledge to leave no one behind reflect the interconnectedness of health and sustainable development, including widening economic and social inequalities, the climate crisis, rapid urbanization, the continuing burden of HIV and other infectious diseases (e.g., malaria, tuberculosis), the growing burden of non-communicable diseases and the emergence of health threats. The scope and scale of delivering health and well-being for all demands innovative partnerships and financing. As affirmed in the Political Declaration of the 2019 High-Level Meeting on Universal Health Coverage (UHC), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), Gavi, the Vaccine Alliance (Gavi) and others are critical partners for delivering on the health-related goals of the 2030 Agenda.  Stronger Collaboration, Better Health: Global Action Plan for Healthy Lives and Well-being for All outlines how a dozen multilateral health, development and humanitarian agencies, including UNDP, the Global Fund, Gavi and others will collaborate to be more efficient and effective in supporting countries to deliver UHC and achieve the health-related SDG targets. 

UNDP’s partnership with the Global Fund, in line with UNDP’s HIV, Health and Development Strategy 2016-2021: Connecting the Dots, makes a vital contribution to UNDP’s Strategic Plan 2018-2021, the 2030 Agenda for Sustainable Development, the SDGs and the pledge to leave no one behind. 

As a long-standing partner of the Global Fund, UNDP’s value proposition lies in providing an integrated package of development solutions to strengthen institutions to deliver health services. Through its contributions as interim Principal Recipient (PR) and provider of technical assistance to Global Fund grants in 53 countries since 2003, UNDP’s provision of integrated policy, implementation and capacity development support to countries has yielded significant health and development results in challenging operating environments. Proactive risk management and investing in sustainability are the cornerstones of UNDP’s portfolio management approach in supporting to countries with significant national capacity constraints to manage large-scale health programmes. By providing technical assistance to national counterparts during all phases of implementation, strengthening legislation, policies and regulatory frameworks, and building capacities across key functional areas, including financial management, health information systems, procurement and supply chain management, UNDP is able to deliver results whilst sustainably transitioning to national entities. UNDP’s track record as PR over the last 17 years and capacity to deliver in challenging operating environments has been critical for strengthening its positioning as a health implementation support partner.

Based on demand from Country Offices, and building on the relationships, expertise, systems, partnerships, including across the UN family, and comparative advantage established through the Global Fund partnership, the GPN/BPPS/Global Fund Partnership/Health Implementation Support Team (GF/HIST, Global Fund Partnership Team) is providing support to Country Offices through three overarching modalities: 1) the Global Fund portfolio, 2) health procurement and supply chain management support, and 3) other health implementation support beyond the Global Fund, including Gavi-funded activities and Solar for Health. The GF/HIST provides its support through a country team approach to strengthen and integrate the different functional capacities (e.g., programmatic, procurement/SCM strengthening, finance, capacity development), leveraging technical assistance and policy support from the HHD Group and other GPN teams.

An increasing number of governments are requesting UNDP to help strengthen national capacities and systems for the provision of health services, especially for the procurement and supply management of medicines and health products.

The primary focus has been medicines and diagnostics for infectious diseases, but it also includes a broad range of laboratory and hospital equipment.  Increasingly, UNDP is receiving requests to support the procurement of medicines, diagnostics and medical equipment for non-communicable diseases. In addition to procurement services, UNDP also supports governments to build resilient and sustainable health systems and support the national procurement and supply chain system. This includes providing technical expertise to strengthen legal, policy and regulatory frameworks, improve procurement rules and regulations, and remove potential barriers to equitable access to affordable medicines.

In line with established best practice, UNDP has a Quality Assurance (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.   

Institutional Arrangement: The Quality Assurance Specialist will report to the GF HIST Quality Assurance Advisor.


Duties and Responsibilities

Objective of the assignment: The Quality Assurance Specialist will support the GFHIST team in the implementation and the monitoring of UNDP’s QA Policy with a focus on MDs and PPE, drawing lessons learnt from UNDP’s support to countries during the COVID-19 pandemic. The Quality Assurance Specialist  will assess the compliance with UNDP QA Policy of MDs, Medical Oxygen Gas & Accessories, and PPE products including their distributors and manufacturers. In addition, the Quality Assurance Specialist will support the development of training packages for use by UNDP’s Country Offices and to develop and revise guidance materials, SOPs and tools and support on training activities for UNDP. The Quality Assurance Specialist will also contribute to corporate reporting on the implementation of the QA Policy during 2022 with a focus on the COVID-19 response and support on training activities. 

 

Scope of Work

  • Provide support to the QA team on the technical and regulatory assessment of MDs, Medical Oxygen Gas & Accessories, and PPEs product dossiers.
  • Provide support for the development of appropriate specifications and QA criteria for key MDs, Medical Oxygen Gas & Accessories, and PPE.
  • Review of international norms and standards to assure continuous alignment of  UNDP’s SOPs and QA Policy requirements.
  • Provide support on the technical issues raised by COs related to the quality of medical devices, Medical Oxygen Gas & Accesories and PPE.
  • Assist the QA team in the maintenance of the QA database of COVID MDs, Medical Oxygen Gas & Accessories, and PPE and in the production of QA corporate reports.
  • Assist the QA Advisor in the communication related to the procurement of MDs, Medical Oxygen Gas & Accessories, and PPE (participation to inter agency meetings, writing of reports).
  • Provide support to the QA Advisor to develop and revise the training packages for use by UNDP’s Country Offices and guidance materials and tools, including the writing of new SOPs and development of related tools;
  • Provide support on QA training activities for UNDP Country Offices and other Business Units. 
  • Provide support and participate to quality audits of MDs, Medical Oxygen Gas & Accessories, and PPEs procurement agencies and suppliers contracted by UNDP.


Competencies

Professionalism:  Shows pride in work and achievements; demonstrates professional competence and mastery of subject matter; is conscientious and efficient in meeting commitments, observing deadlines and achieving results; is motivated by professional rather than personal concerns; shows persistence when faced with difficult problems or challenges; remains calm in stressful situations. Takes responsibility for incorporating gender perspectives and ensuring the equal participation of women and men in all areas of work.

Communication: Speaks and writes clearly and effectively; Listens to others, correctly interprets messages from others and responds appropriately; Asks questions to clarify and exhibits interest in having two-way communication; Tailors language, tone, style and format to match the audience; Demonstrates openness in sharing information and keeping people informed.

Client Orientation: Considers all those to whom services are provided to be "clients " and seeks to see things from clients' point of view; Establishes and maintains productive partnerships with clients by gaining their trust and respect; Identifies clients' needs and matches them to appropriate solutions; Monitors ongoing developments inside and outside the clients' environment to keep informed and anticipate problems; Keeps clients informed of progress or setbacks in projects; Meets timeline for delivery of products or services to client.


Required Skills and Experience

Min. Academic Education

Master’s degree in Pharmacy, Pharmaceutical Quality Assurance, Pharmacology/Hospital pharmacy  or equivalent biomedical qualification .

Min. years of relevant Work experience

  • At least 7 years’relevant progressive experience in quality assurance of health products.

Required  skills and competencies

  • Good knowledge of WHO norms and standards and international regulations for medical devices, medical oxygen gas & accessories, and personal protective equipment.
  • Experience in the procurement and supply chain management of medical devices for health facilities.
  • Experience with partner coordination and collaboration including with Government agencies.

Desirable skills and competencies

  • Experience in the quality assurance of medical devices, medical oxygen gas & accessories, and personal protective equipment, including technical and regulatory assessment of product’ dossiers.
  • Experience working with international humanitarian organizations or a UN Agency.
  • Experience within medical devices national regulatory authorities.
  • Experience as hospital pharmacist or medical devices hospital referent.
  • Experience in medical devices market assessment and suppliers audit.
  • Set-up and/or management of codification systems (in-house or international).
  • A second UN language.

Required Language(s) (at working level)

  • Fluency in English both written and oral.



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