United States Pharmacopeial Convention Senior Technical Officer, CMC and Regulatory Systems Strengthening Jobs in Ethiopia
United States Pharmacopeial Convention Senior Technical Officer, CMC and Regulatory Systems Strengthening Jobs in EthiopiaJob DescriptionThe U.S. Pharmacopeia Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Roles and Responsibilities
Provides technical oversight of activities to support local manufacturers in Ethiopia to implement and comply with GMPs and in the development of dossiers to submit for WHO prequalification.
Leads in the provision of technical assistance to EFDA particularly in the areas of good manufacturing practice (GMP) compliance audit and pharmaceutical product dossier evaluation.
Designs and implement interventions aimed at strengthening overall regulatory systems and improving medicine quality assurance systems in Ethiopia including the development and implementation of regulations, directives, manuals, guidelines, procedures and other relevant tools.
Provides technical leadership and ongoing support to EFDA to improve efficiency and effectiveness of the medicine marketing authorization process.
Manages technical assistance and advises in the development of tools for marketing authorization, clinical trial approval and compliance to good clinical practice (GCP).
Provide training in dossier assessment, GMP compliance, good distribution practice (GDP), good storage practice (GSP) and good inspection techniques for staff at EFMHACA and regional/city administration regulatory bodies.
Support building capacity of regional medicine regulatory bodies in the development of regulatory tools and inspection of the distribution channel and retail outlets of pharmaceutical products.
Work closely with country team to support development and deployment of strategies in pharmaceutical sector development
Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
Minimum of 8 + years of experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals
Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
Working understanding of Chemistry,
Manufacturing and Controls, good manufacturing practices, dossier evaluation and inspection
Direct experience implementing USAID-funded programs
Direct experience with and understanding of WHO pre-qualification process Strong written (especially technical writing) and oral communication skills
Experience of working with EFDA and/or local manufacturers
Willingness to travel at least 25% of the time.
Minimum 3+ years of people management experience and skills
Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
How to Apply
Please send CVs to the email address GPHEthiopiaRecruitment@USP.org
Click here to post comments
Join in and write your own page! It's easy to do. How? Simply click here to return to Job Vacancies in Africa.