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Consultant-Strengthening Quality Local Production Of Vaccines And Biotherapeutic Products
• Genf
Beratungs-/ Consultingtätigkeiten
[...] preparation for vaccines and/or biotherapeutic products under current international quality standards. Relevant professional experience in the manufacturing industry of medical products or their regulatory control including: Experience in a national regulatory authority as a CMC/ quality, non-clinical, clinical and/or pharmacovigilance
assessor of vaccines/ biotherapeutic products. Experience with the WHO Prequalification and/or Emergency Use Listing procedures. Experience in organizing and/or providing capacity building/ training for development, manufacturing, and regulation of medical products in low-and middle-income countries. Experience in technology transfers. Experience in an international organization. Strong knowledge of the manufacturing processes, CMC, non-clinical and/or clinical development, post-marketing safety documentation and product dossier requirements of vaccines and/or biotherapeutic 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/or biotherapeutic 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. Knowledge of current WHO and/or other internationally recognized standards of GMP and/or quality management systems of manufacturing facilities of vaccines and/or biotherapeutic products. Knowledge of technology transfers for vaccines and/or biotherapeutic/ pharmaceutical products. Knowledge of the CMC, non-clinical and/or clinical development, post-marketing safety, GMP and/or product dossier requirements of medicines in accordance with WHO and/or internationally recognized standards. Languages required: Essential: Expert [...]
