The Regulation and Prequalification Department works with Member States and partners to improve access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The department works within the Access to Medicines and Health Products Division in the wider framework of Universal Health Coverage and cooperates with disease-oriented programmes (such as HIV/AIDS, tuberculosis, malaria, reproductive health, maternal and child health, immunization, non-communicable diseases and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The Local Production and Assistance Unit (LPA) supports Member States in a holistic manner to promote and strengthen local production and technology transfer to improve access to quality-assured health products, reduce dependency on imports to strengthen national health security, stimulate local capacities for sustainable and quality production, innovation and of the health workforce, and stimulate a knowledge-based economy. LPA supports Member States, particularly low- and middle-income countries in strengthening local production of quality-assured essential medical products, including development of strategies, policies and tools, capacity-building, technical assistance, facilitation of technology transfer and fostering partnerships and collaborations. DESCRIPTION OF DUTIES
Under the supervision and overall guidance of the Unit Head, Local Production and Assistance Unit, the incumbent will assist LPA with the following tasks:
Organize and conduct capacity-building and technical assistance activities to strengthen local production of specific medical products and ensure quality assurance throughout the local production process (i.e. training for Member States on e.g. Good Manufacturing Practices (GMP), quality management systems, facility design, technology transfer);
Prepare a strategy for interactive, “hands-on” capacity building for relevant stakeholders to strengthen local production and technology transfer of quality-assured medical products;
Prepare training materials and other technical documents related to local production and technology transfer of medical products for capacity building and technical assistance of Member States;
Conduct gap analysis towards identifying gaps and needs-based technical assistance and/or assessing feasibility and readiness in strengthening quality and sustainable local production of medical products by Member States;
Conceive and organize technical briefing seminars, regional and global technical and coordination meetings with experts, partners and collaborative networks;
Perform other related tasks as assigned.
REQUIRED QUALIFICATIONS
Education
Essential: Advanced level university degree in pharmacy, life sciences or other health or socio-economic related fields.
Desirable: Advanced university degree related to development and/or production of vaccines and/or biological products, such as immunology, biochemistry, cellular biology or biotechnology.
Experience
Essential: A minimum of seven years of relevant professional experience, including some years of which are gained in an international context, in the production, quality assurance of vaccines and/or biological products and in conducting GMP audits under current WHO/international GMP standards.
Desirable: Relevant professional experience:
in the medical product manufacturing industry including experience in conducting GMP audits;
in a national regulatory authority as a GMP inspector of vaccine/biological product manufacturers;
in facility design for the vaccine/biological product and/or pharmaceutical manufacturing industry;
with the WHO Prequalification and/or Emergency Use Listing procedures;
in organizing and/or providing capacity building/training for quality production of medical products in low- and middle-income countries;
in technology transfers;
and/or with an international organization.
Skills
Essential:
Sound knowledge of manufacturing, current Good Manufacturing Practices and/or quality management systems and regulation for vaccines and biological products;
Knowledge of WHO and other internationally recognized quality assurance standards, WHO emergency listing and/or prequalification procedures and/or health product regulation for vaccines and biological products;
Ability to review, revise or develop technical documents, policies and activities in the area of local production and technology transfer of medical products;
Ability to design, plan and implement activities to achieve the goal(s);
Excellent communication and interpersonal skills, strong planning and organizational skills and ability to use a range of IT tools (Word, Excel, presentation software, databases and web navigators;
Demonstrated ability to interact with all stakeholders with tact and diplomacy, upholding the reputation of the Organization at all times.
Desirable:
Knowledge of the manufacturing processes, chemistry, manufacturing and controls (CMC) and/or product dossier requirements of vaccines and/or biological products in accordance with current WHO/internationally-recognized standards;
Knowledge of the manufacturing processes, CMC, GMP and/or product dossier requirements of medicines in accordance with current WHO and/or internationally-recognized standards.
WHO Competencies
Teamwork
Respecting and promoting individual and cultural differences
Communication
Producing results
Building and promoting partnerships across the organization and beyond
Use of Language Skills
Essential: Expert knowledge of English.
Desirable: Intermediate knowledge of another official UN language (Arabic, Chinese, French, Russian, Spanish).
