Consultant –Local production and assistance in Product Chemistry, Manufacturing and Controls (CMC)/Quality and Dossier at World Health Organization

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.