Regulatory System Strengthening Consultant - Medicine Quality
Job Description
Title: Regulatory System Strengthening Consultant - Medicine Quality
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Anywhere in Bangladesh
Employment Status: Contractual
Educational Requirements:
∎ Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering, or related sciences.
Experience Requirements:
∎ At least 8 year(s)
Job Context:
∎ Our USAID donor-funded program, Promoting the Quality of Medicines Plus (PQM+), seeks a consultant with expertise and experience in the following technical areas to respond to USAID`s COVID-19 response efforts in Bangladesh.
∎ Anticipated consultancy timeline:
∎ Full time consultant for 6 months
∎ Time period between June 2020 - November 2020
Job Responsibilities:
∎ Area of Work:
∎ The consultant will provide technical assistance to the Directorate General for Drug Administration (DGDA), National Control Laboratory (NCL), and manufacturers to strengthen their quality management systems and build capacity to ensure the quality of medical products related to COVID-19. The consultant must possess a deep understanding of quality management systems for medicines regulatory authorities and pharmaceutical companies to provide technical oversight for strengthening the capacity of laboratories responsible for assessing the quality of medical products. With oversight from PQM+ country office and technical leadership, the consultant will work to implement the following activities:
∎ I. Regulatory Systems Strengthening for Risk-based approach to product registration
∎ Support DGDA to develop a risk-based strategy for registration of COVID-19 related medical products
∎ Work with DGDA to categorize COVID19 medical products in terms of potential for compromise to quality during manufacture
∎ Develop a COVID19 medical product job aide for DGDA reviewers and inspectors
∎ Based on the job aide, develop information materials that can be shared with manufacturers
∎ II. QC lab strengthening:
∎ Support the NQCL to adopt a risk-based approach for testing of COVID-19 related medical products
∎ Develop risk-based protocol for testing of COVID19 medical products
∎ Map lab needs for carrying out testing as per protocol
∎ Deliverables:
∎ Development of an implementation plan based on this SOW
∎ Prepare general guidance on risk-based/priority approach to medical product registration
∎ Prepare COVID-19 medical product job aide for reviewers and inspectors
∎ COVID-19 medical product information (based on job aide) shared with manufacturers
∎ Risk-based testing protocol for COVID-19 medical products
∎ Costed report of lab needs for COVID-19 medical product quality testing
∎ Weekly progress reports
∎ Submission of a final report at the end of this consultancy to include in an Annex a full contact list of stakeholders with name, title, phone, email
Additional Requirements:
∎ Extensive [8+ years] relative experience in leading and providing technical assistance to quality control laboratories
∎ Good understanding of current covid-19 related situation and response
∎ Good relationships/network with key clinical laboratory stakeholders across Bangladesh
∎ Good understanding of medicine quality testing and field level surveillance.
∎ Experience in technical report writing, SOP development, and knowledge of global health development donors, including USAID, CDC, and other multilateral donors and foundations
∎ Understanding about DGDA regulatory functions
∎ Excellent technical writing skills, experience with gap analyses
∎ Preferred:
∎ Good understanding about DGDA (NCL) drug testing laboratory
∎ Understanding and working experience with WHO, INGOs, Govt. agencies that are implementing regulatory system and laboratory system strengthening programs.
∎ Anticipated consultancy timeline:
∎ Full time consultant for 6 months:
∎ Time period between June 2020 - November 2020
Application Deadline: 25 Jun 2020
Company Information:
∎ 20 Jun 2020
∎ U.S. Pharmacopeial Convention
∎ Business : The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization founded in 1820. It 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.
Category: NGO/Development
