Title: Personal Protective Equipment (PPE) Consultant
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Anywhere in Bangladesh
Employment Status: Contractual
Educational Requirements:
∎ Degree in Biomedical engineering/Chemical Engineering/Textile Engineering/ Laboratory sciences or relevant health engineering field
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
∎ Time period between June 2020 - November 2020.
∎ This consultancy may be extended (dependent on availability of fund).
Job Responsibilities:
∎ Area of Work:
∎ The main focus of this consultancy is to strengthen quality assurance systems for the manufacturing of PPE and medical devices such as ventilators, in response to COVID-19 challenges. With technical oversight from PQM+, the consultant will provide technical assistance to the Directorate General for Drug Administration (DGDA), National Control Laboratory (NCL), and relevant stakeholders (e.g. WHO and manufacturers), to implement technical assistance efforts in the following areas.
∎ 1. Local manufacturing of PPE for Regulatory systems strengthening:
∎ Support local manufacturers to strengthen quality assurance of Personal
∎ Protective Equipment (PPE)
∎ Work with WHO consultant to review checklist for visual inspection of PPE
∎ Work with DGDA to establish (by Aug) and keep up to date (ongoing) a database of existing PPE suppliers
∎ Develop guidance for manufacturers based on quality considerations included in visual inspection checklist for PPE
∎ Develop guidance for procurement agents based on quality considerations included in visual inspection checklist for PPE
∎ 2. Medical device registration:
∎ Assist DGDA to draft authorization checklist/guidance for ventilators based on
∎ current best practices
∎ Review existing guidelines and documentation of best practices for authorization of ventilators
∎ Draft checklist/guidance for ventilators and ask for review by national experts
∎ Finalize checklist/guidance and orient DGDA staff on its use
∎ Deliverables:
∎ WHO visual inspection checklist reviewed and finalized with inputs from PQM+
∎ PPE supplier database
∎ Guidance document for manufacturers based on checklist
∎ Guidance document for procurement agents based on checklist
∎ Checklist/guidance for use authorization for ventilators by DGDA
∎ Weekly progress reports
∎ Submission of a final report upon completion of this SOW that includes an Annex with a full contact list of stakeholders with name, title, phone, email
Additional Requirements:
∎ Advanced knowledge and understanding of Biotechnology, Biomolecular, PPE (Musk, Gowon), Medical devices (e.g., ventilators.)
∎ Good understanding of current covid-19 related situation and responses
∎ Good understanding of Laboratory setting of PPE testing and manufacturing of ventilator
∎ Good relationships/network with key PPE testing laboratory and stakeholders across Bangladesh
∎ Experience in technical report writing, SOP development, and knowledge of global health development donors, including USAID, CDC, and other multilateral donors and foundations
∎ Excellent technical writing skills, experience in conducting gap analyses
∎ Preferred skills are:
∎ Good understanding about PPE and Medical devices, Biosafety and biohazard
∎ Understanding and working experience with WHO, INGOs, Govt. agencies that are implementing regulatory system and laboratory system strengthening programs.
∎ Ability to assist with PPE testing related lab and provide technical input
∎ Ability to present and communicate report with stakeholder's and decision makers
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