: Full-time IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings.
OBJECTIVES OF THE PROGRAMME
The Department of Essential Medicines and Health Products (EMP) works with Member states and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The EMP department works with the HIS cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Millennium Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The department has three large areas of work: (1) Regulation of Medicines and other Health Technologies (RHT) unit (covering medicines, vaccines, other biologicals, blood products, medical devices and diagnostics), which consists of four teams covering the normative and standard setting work, the prequalification of medicines, vaccines and diagnostics for UN and international procurement, the strengthening of regulatory systems and networks, and the safety and vigilance of health technologies. RHT is also responsible for work on detection and prevention of substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products.(2) Policy, Access and Use team, which includes the Expert Committee of Selection and Use of Essential medicines, and the Expert Committee on Drug dependence, and covers the work on national policies, procurement, supply management and pricing of health technologies.(3) Public Health, Innovation and Intellectual Property team which covers the Global Strategy and Plan of Action on Public health, Innovation and Intellectual property, and works with countries on local production and transfer of technology approaches; and on strategies for management of intellectual property issues.The objective of the Prequalification Team (PQT) is to enhance access to health technologies (medicines, vaccines, diagnostics and devices) for priority diseases. Through the prequalification process, it assures the quality, safety and efficacy of appropriate health technologies and active pharmaceutical ingredients (API) to be available for procurement through or with funds from the UN system or global procurement agencies. The list of prequalified health technologies is subsequently used by national procurement agencies and non-governmental organizations (NGOs).
DESCRIPTION OF DUTIES
To provide technical guidance to the department and team aiming at highest level of quality, efficacy and safety in the provision of selection and appropriate use of essential health technologies. More specifically the incumbent should, under the supervision of the Group Lead, Inspection Services:1. coordinate the scheduling and conduct inspections of manufacturing lines of diagnostics for the Inspection Services team;2. oversee the development, review, updating and finalizing of guidelines related to inspection of manufacturing processes of diagnostics for prequalification;3. provide technical support as related to quality management systems to WHO EQA scheme providers and of laboratories conducting post market surveillance of diagnostics;4. provide technicalguidance and support the development of training materials and facilitate the WHO training activities on implementation and assessment of quality management systems of manufacturing lines of diagnostics in collaboration with regions;5. contribute to the development of information and documents for PQT web pages in particular those related to prequalification of diagnostics; and6. perform other duties, as assigned by the Group Lead, Inspection Services and Coordinator, PQT.
REQUIRED QUALIFICATIONS
Education
Essential : 1. Advanced university degree (Master's level or above) in a related health science such as Biomedical Sciences, microbiology, biology.2. Certified inspector/auditor of a recognized body for QMS for Medical Devices including IVDs.
Desirable : Certificate or equivalent in a related health science such as Physical Sciences (instrumentation) or Biomedical sciences relevant for research, manufacture and control of medical devices with a focus to in-vitro diagnostics.
Experience
Essential : At least seven years work experience in manufacturing, research or regulation in the area of diagnostics and laboratory technology. At least three years of experience with inspections and/or compliance with ISO 13485 and quality management systems for laboratories and manufacturing lines of diagnostics. Work experience collaborating with industry.Practical working experience with the International Medical Devices Regulatory Forum (IMDRF) Medical devices and/or Single Audit Program (MDSAP) and related documents on Quality Management System, guidance documents, audit tools, and monitoring and assessment program.
Desirable : Experience working within the regulation authority at a national level would be an asset.Experience working on collaboration with different regulatory systems at the regional or international level would be added asset.
Skills
1. Excellent knowledge and practical application of ISO 13485 Quality Management Systems (QMS) and related ISO standards.2. Sound knowledge of regulatory affairs in medical devices including in-vitro diagnostics.3. Proven ability to write technical reports, in particular inspection reports.4. In depth understanding of the diagnostic industry.5. Excellent interpersonal and communication skills, ability to establish and maintain effective working relationships with international and national staff at all levels.6. Motivation to work in an international environment and in a team.
WHO Competencies
Producing results
Teamwork
Communication
Building and promoting partnerships across the organization and beyond
Respecting and promoting individual and cultural differences
Use of Language Skills
Essential : Expert knowledge of English.
Desirable : Beginners knowledge of French.
REMUNERATION
WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 72,637 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 4092 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.
ADDITIONAL INFORMATION
This vacancy notice may be used to fill other similar positions at the same grade level
Only candidates under serious consideration will be contacted.
A written test may be used as a form of screening.
In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: www.whed.net/ . Some professional certificates may not appear in the WHED and will require individual review.
Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
For information on WHO's operations please visit: www.who.int.
WHO is committed to workforce diversity.
WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
WHO has a mobility policy which can be found at the following link:www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
