About the Role
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.
Deliverables:
The consultant will provide:
- Specialized Prequalification (PQ)-related technical assistance, for up to 10 manufacturers such as assessments/verification of the quality/CMC aspects and the dossier of vaccines and other biological/pharmaceutical products with the relevant documents (e.g. reports).
- PQ-related specialized technical assistance for up to 10 manufacturers with on-site/virtual training and/or technical assistance on the quality/CMC aspects and/or dossier of vaccines and other biological/pharmaceutical products, and the relevant documents (e.g., concept note, agenda, reports).
- Technical input for a standard operation procedure for provision of PQ-related specialized technical assistance to manufacturers of vaccines and other biological products and deliver relevant documentation (e.g. SoP document).
- On-site reviews of dossiers of vaccines and/or biological/pharmaceutical products for compliance with current WHO/international quality standards and requirements, including for WHO PQ/EUL, conducted in up to 4 countries and preparation of relevant documents (e.g. reports).
- At least 2 capacity building activities and technical assistance activities, organized and conducted for relevant stakeholders in the areas of CMC/quality, dossiers, etc. of vaccines and/or biological/pharmaceutical products with the relevant documents (e.g. concept note, agenda).
- Training materials prepared related on the quality/CMC aspects of vaccines and/or other biological/pharmaceutical products.
- Technical input on the technical products of the LPA Unit, such as ”frequently asked questions” documents, with collaboration from relevant colleagues.
Qualifications, experience, skills and languages
Educational Qualifications:
Essential:
- Advanced university degree in pharmacy, sciences, 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:
- At least seven years of relevant experience, some of which at the international level, in the production, CMC, quality control and dossier preparation for vaccines and/or biological products under current international quality standards.
Desirable:
Relevant professional experience in the medical product manufacturing industry including:
- Experience in the production, CMC and/or quality control of vaccines/biological products;
- Experience in a national regulatory authority as a CMC/quality assessor of vaccines/biological products;
- Experience with the WHO Prequalification and/or Emergency Use Listing procedures;
- Experience in organizing and/or providing capacity building/training for quality production of medical products in low- and middle-income countries;
- Experience in technology transfers; and/or in an international organization.
Skills/Knowledge:
Essential:
- Strong knowledge of the manufacturing processes, CMC and product dossier requirements of vaccines and biological products in accordance with WHO and/or internationally-recognized standards;
- Knowledge of current 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 and activities in the area of local production 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 current WHO and/or other internationally recognized standards of GMP and/or quality management systems of manufacturing facilities of vaccines and biological products;
- Knowledge of technology transfers for vaccines and/or biological/pharmaceutical products;
- Knowledge of the CMC, GMP and/or product dossier requirements of medicines in accordance with WHO and/or internationally-recognized standards.
How to Apply
https://careers.who.int/careersection/ex/jobdetail.ftl?job=2211040&tz=GMT%2B01%3A00&tzname=Africa%2FLagos&utm_source=MyJobMag