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Lead and coordinate the technical development and implementation of in-country COVID-19 vaccine manufacturing and regulatory work plan activities
Provide technical assistance to COVID-19 mRNA vaccines manufacturers on development, commissioning, qualification and validation of vaccine fill/finish and packaging processes.
Partner with USP and PQM+ technical team members, consultants, other PQM+ countries, vendors, and local stakeholders to assure adequate manufacturing facility design and startup.
Provide support to strengthen the National Medicines Regulatory Authority (NMRA) legal framework for vaccines manufacturing, supply, storage, distribution, and handling
Support NMRA and national control labs in the development of lot release testing capacity and in the implementation of vaccine post-marketing surveillance. Also support the GMP inspectorate of the NMRA to strengthen its capacity for regulatory oversight of vaccine manufacturers.
Liaise with HQ Vaccines Director to develop appropriate training materials and to organize the delivery of training programs targeted to local vaccine manufacturers, regulators, and quality laboratory staff.
Support manufacturers in addressing deviations and non-compliances, in conducting audits to assess compliance and the establishment of cGMPs; also, in filing of vaccine dossiers for market authorization according to NMRA’s requirements.
Coordinate efforts aimed at the identification of needs for manufacturing and laboratory equipment, materials, and processes in support to successful local production and quality assurance of COVID-19 vaccines.
Support manufacturers to identify chemistry, manufacturing, and controls (CMC) risks and continuous improvement opportunities
Gather programmatic data and develop progress reports as guided by the PQM+ HQ Vaccines Director. Also, support the development of technical and communication materials related to local manufacturing and quality of vaccines.
Basic Qualifications
Bachelor of Science degree in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study required
Twelve (12) years of experience in vaccines and biologics manufacturing or regulation
Skills Sought
Subject matter expert in vaccine/biopharmaceutical fill/finish and packaging processes
Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for vaccines and medicines e.g., fill and finish
Knowledge of regulatory requirements related to the development and manufacture of biologics
Strong technical writing and oral communication skills
Proficiency in French
Willingness to travel up to 25% of the time
Preferred Qualifications
Master of Science or PhD in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study
Understanding of GMP manufacturing of biologics, including vaccines
Understanding of compatibility and stability studies
Understanding of cold chain monitoring
Understanding of fill/finish and packaging processes for mRNA vaccines
Direct experience with and understanding of WHO vaccine pre-qualification and/or other regulatory authority registration processes
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