Consultant – Strengthening quality local production of in-vitro diagnostics and other devices

JOB DESCRIPTION

..

Qualifications
Purpose of consultancy

To provide technical expertise to the Local Production & Assistance (LPA) Unit with programme activities in strengthening local production and technology transfer for improving access to quality-assured, safe and effective in-vitro diagnostics and other medical devices.

Background

The COVID-19 pandemic has shown a concentration of global production capacity of essential health products in a few regions/countries and vulnerabilities in global supply chains. For low- and middle-income countries (LMICs) that rely largely on importation of medical products to meet public health demands, they are at greater risk for lack of access to quality-assured medical products. The LPA Unit has been receiving requests from Member States for support in strengthening quality local production and technology transfer as many LMICs look to technology transfer and strengthening local manufacturing capacity to improve timely access and strengthen national health security, particularly during emergencies such as the COVID-19 pandemic.

The Local Production and Assistance (LPA) Unit in the Regulation and Prequalification (RPQ) Department is responsible for supporting Member States in strengthening local production and technology transfer of quality-assured essential health products to improve access under the context of WHA74.6 on Strengthening local production of medicines and other health technologies to improve access and other WHA resolutions and decisions related to local production and access to health products. The focus of work is on promoting sustainable quality local production and technology transfer in a holistic manner, such as conducting feasibility assessments for sustainable local production, developing strategies, roadmaps and tools, providing capacity building and specialized technical assistance and facilitating technology transfer.

Deliverables:

• Organize and/or conduct up to 6 capacity building and technical assistance activities to relevant stakeholders on local production and/or technology transfer of quality-assured IVDs and/or medical devices and prepare the relevant materials (e.g. agenda, pre-workshop documents).
• Facilitate organizing and/or providing specialized technical assistance related to WHO Prequalification (PQ) or Emergency Use Listing (EUL) for up to 8 manufacturers of in-vitro diagnostics (IVDs) and prepare the relevant documents (e.g. reports).
• Prepare training materials related to the sustainable local production of quality, safe and effective IVDs and other devices.
• Contribute to organizing up to 6 fora, meetings, etc. related to local production and technology transfer organized by or involving the LPA Unit as assigned and prepare relevant materials.
• Contribute to the drafting of technical products related to local production and technology transfer of in-vitro diagnostics and other devices, such as "frequently asked questions" documents, etc.
• Contribute to the preparation and/or development of research/evidence-based documents related to local production and technology transfer of in-vitro diagnostics and other devices, such as surveys and literature reviews.

Qualifications, experience, skills and languages.
Educational Qualifications:

Essential:

• First level university degree in a field related to pharmacy, sciences, life sciences (such as biochemistry, immunology, biotechnology, and biomedical engineering) or other health or science-related fields.

Desirable:

• First level university degree in a field related to the design, development, manufacture and/or performance evaluation of IVDs.

Experience

Essential:

• A minimum of three years of professional experience in the design, development, manufacture, quality management system (QMS) audit and/ or product dossier review, performance evaluation, quality control and/or regulation of IVDs in accordance with WHO or internationally recognized quality standards.

Desirable:

• Professional experience working for an IVD manufacturer.
• Professional experience in implementing current international standards for QMS and risk management systems in a manufacturing facility of IVDs.
• Professional experience in conducting QMS audits of local and overseas manufacturers of IVDs in accordance with current international regulatory standards.
• Professional experience working in a national regulatory authority (NRA) for regulating IVDs and medical devices in accordance with current. national/international regulatory standards, e.g. assessing the product technical file for quality, inspecting the QMS of local and overseas manufacturing facilities, and/or conducting performance evaluation tests.
• Professional experience working for a medical/clinical laboratory, particularly for communicable diseases.
• Experience with the clinical development and/or evaluation of IVDs.
• Experience with the submission of the product technical file and other regulatory documents to the NRA/certified notification body for life cycle management of the IVD in the local, regional and/or international market(s).
• Experience with WHO PQ and/or EUL for IVDs.
• Experience in organizing meetings/workshops and providing training.
• Experience in, or in collaboration with, an international organization.
• Experience working in LMICs.
• Experience with technology transfers related to IVDs and/or medical devices.

Skills/knowledge

• Technical knowledge in the design, development, manufacture, quality control and/or performance evaluation of IVDs.
• Technical knowledge in WHO and other internationally-recognized quality assurance standards for IVDs and medical devices (e.g. ISO, GMP).
• Excellent writing skills.
• Good communication and interpersonal skills with the ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders.
• Strong methodological and analytical skills with the ability to conduct research, identify and analyse literature relevant to the programme area.
• Good planning and organizational skills with attention to detail and with the ability to multi-task and work under pressure.
• Strong IT skills: Word, Excel, presentation software, databases and web navigators.
• Technical knowledge in the regulation of IVDs and medical devices.
• Technical knowledge of the requirements for the WHO PQ and/or EUL for IVDs.
• Technical knowledge in the laboratory diagnosis of communicable diseases.
• Technical knowledge in the design, development, manufacture, quality control and/or performance evaluation of medical devices.
• Knowledge in the ecosystem for sustainable local production of IVDs and medical devices.
• Knowledge in the transfer of technology for IVDs and/or medical devices.

Languages required:

Essential:

• Expert knowledge of English.

Desirable:

• Working knowledge of another WHO official language.

Location

Off-site – Home based.

Travel

The consultant is expected to travel to the manufacturing facility for PQ-related technical assistance.

Remuneration and budget (travel costs are excluded):
Remuneration:

Band level A – USD 3,955 – 6,980 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

2 to 11 months.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for 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: Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit:
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: fonctionnaires et

Apply for job

To help us track our recruitment effort, please indicate in your cover/motivation letter where ) you saw this job posting.

---