Consultant for Technical Assistance to EDCLs Vaccine Project
Job Description
Title: Consultant for Technical Assistance to EDCLs Vaccine Project
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Contractual
Educational Requirements:
∎ Pharmaceutical sciences/regulatory affairs/ development and management studies or related field, vaccine science will be an asset.
Job Context:
∎ Who is USP?
∎ The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world`s top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP`s fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hard-working professionals across five global locations to deliver the mission to build a stronger supply of safe, quality medicines and supplements worldwide.
∎ The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems-strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as improve maternal, newborn, and child health.
∎ Brief Job Overview: The Promoting the Quality of Medicines (PQM) plus program is funded by USAID and led by United States Pharmacopeial Convention Inc. (USP). USP supports DGDA (Directorate of Drug Administration) to achieve WHO maturity level-3 and the National Drug Control Laboratory (NDCL) of the DGDA to become a WHO-prequalified laboratory that meets international standards & harmonizing with another national Regulatory Authority (NRA) labs. Through the technical assistance from the PQM+ program, the NDCL in Dhaka was accredited by Bangladesh Accreditation Board (BAB); ISO/IEC 17025:2017 by ANSI-ASQ National Accreditation Board and achieved WHO-PQ. PQM+ works with Pharmaceuticals Manufacturers and provides technical support to produce priority medicines in Bangladesh.
∎ The Government of Bangladesh, through the Asian Development Bank (ADB) funding project ``Vaccines, Therapeutics, and Diagnostics Manufacturing and Regulatory Strengthening (VTDm-RS) under the Asia-Pacific Vaccine Access Facility (APVAX) has tasked the state-owned enterprise Essential Drugs Company Limited (EDCL) with developing a Biotech Research Centre and a Biotech manufacturing plant in Gopalganj district.
∎ Duration of the assignment: Start Date to 30 September 2024, with possible extension.
∎ Workstation/Service Delivery place: The consultant will work with EDCL and MOHFW assigned personnel. S/he will also work at USP office.
∎ Legal Document required: As per the government, the consultant must have the Tax Identification number (TIN) with Proof of Submission of Return (PSR) and Business Identification Number (BIN) number.
Job Responsibilities:
∎ How will YOU create impact here at USP?
∎ The consultant will collaborate with EDCL to provide technical expertise in the development of the vaccine manufacturing project. The objectives include review the Development Project Proposal (DPP), addressing observations from the Ministry of Planning and ADB during the approval and implementation process, and facilitating understanding of the WHO prequalification application process and its linkage with DGDA's WHO GBT ML3 for vaccines. The specific tasks are-
∎ Collaborate with EDCL vaccine project team (Dhaka) in reviewing the Development Project Proposal (DPP), addressing technical aspects, and ensuring alignment with GMP standards.
∎ Provide technical inputs to address observations from the Ministry of Planning and ADB during the approval and implementation of the project.
∎ Work with EDCL to identify specific technical areas requiring long-term support for successful project implementation.
∎ Conduct consultative meetings with EDCL management and the vaccine project team to explain the WHO prequalification application process, timeframe, and its linkages with DGDA's WHO GBT ML3.
∎ Assist in understanding domestic and export market requirements for vaccine products.
∎ Visit vaccine manufacturing site time to time with the EDCL vaccine project team.
∎ Work in collaboration with PQM+ project management and activity lead.
∎ Deliverables:
∎ Progress report on the technical support provided to review the Development Project Proposal (DPP) and
Additional Requirements:
∎ Who USP is Looking For?
∎ USP is looking for an individual consultant to complete the assignment. The consultant should bring the following qualifications and experiences:
∎ Pharmaceutical Project Management: Proven experience in managing pharmaceutical projects, especially in vaccine manufacturing.
∎ Regulatory Affairs: Expertise in navigating regulatory requirements, particularly in relation to WHO prequalification and FDA approval.
∎ Technical Expertise: In-depth knowledge of vaccine manufacturing processes, GMP standards, and pharmaceutical sector strategy.
∎ Project Approval Process: Experience in developing policy and strategic plans for GoB, addressing observations, and facilitating the approval process with government bodies and international funding agencies.
∎ Good understanding of public health systems
∎ Consultation and Communication: Strong facilitation skills to conduct consultative meetings and effectively communicate complex technical information.
∎ Documentation and presentation skill
∎ Additional Desired Preferences:
∎ Proof of implementing effective, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects
∎ Experience in implementing technical assistance programs in expanding access to global health products and pharmaceuticals.
∎ Good understanding of and experience working with USAID compliance rules and regulations
∎ Significant experience working with high-level officials in USAID and country governments.
∎ Excellent client relationship management skills
∎ Excellent written and verbal communication skills
∎ Ability to work in cross-cultural settings.
∎ Ability to demonstrate the highest degree of ethics and integrity.
∎ Willingness to travel
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 6 Jan 2024
Company Information:
∎ 28 Dec 2023
∎ U.S. Pharmacopeial Convention
Category: NGO/Development
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