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Users and Survivors of Psychiatry in Kenya (USP Kenya) welcomes all members of the public and relevant stakeholders to be partners in promoting the human rights discourse of persons with psychosocial disabilities.
The Senior Technical Officer, Chemistry, Manufacturing and Controls (CMC) and Regulatory Systems Strengthening (RSS) will have expert skills in pharmaceutical manufacturing, dossier evaluations/submission and inspection. He/she must understand the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will be responsible for providing specialized technical assistance in the areas of regulatory systems strengthening with emphasis on dossier assessment/evaluation and conducting manufacturing facility audits for compliance to current Good Manufacturing Practice (GMP). He will initiate the development of regulations, directives, manuals, guidelines, procedures and other relevant tools and promotes their proper implementation. The incumbent will serve as a focal point for initiatives to build capacity of manufacturers in order to institute good practices for ensuring medicines quality at various stages including medicine production, registration, market authorization/ licensing and inspection. As the lead for PQM+ pharmaceutical manufacturing and regulatory activities in the region, the Senior Technical Officer provides technical oversight related to the program’s objective of increasing the supply of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, product development, good manufacturing practices, dossier development and submission).
Roles And Responsibilities
Basic Qualifications
Preferred Qualifications
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