Consultant - TB Program Coordinator
Job Description
Title: Consultant - TB Program Coordinator
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Anywhere in Bangladesh
Employment Status: Full-time, Contractual
Educational Requirements:
∎ Preferably a medical graduate
Experience Requirements:
∎ At least 6 year(s)
Job Context:
∎ Full time consultant for 6 months
∎ Time period between May 2021 - October 2021
Job Responsibilities:
∎ Provide assistant to Local Public manufacturers (SOE-EDCL) to produce first line anti-TB medicines to progress towards achieving WHO-PQ
∎ Provide assistance to a private manufacturer to accomplish Bioavailable/ Bioequivalence (BA/BE) study of first line anti TB medicines.
∎ Provide support to DGDA & NCL to implement RB-PMS of TB medicine
∎ Rapid assessment on SF TB medicine
∎ Coordinate with DGDA, DGHS and NTP during conducting Post Market Surveillence (PMS), GMP training to EDCL technical staff, Rapid assessment of SF anti TB medicine.
∎ Work with EDCL to identify potential trainees for GMP training.
∎ Work with EDCL and PQM+ team to develop training plan and implement training program.
∎ Prepare training report and conduct evaluation of training.
∎ Work with ACI Pharmaceuticals and PQM+ technical officer to follow-up progress in addressing CAPA.
∎ Work with PQM+ HQ GMP expert to provide technical assistance (TA) to ACI Pharma
∎ Follow-up B/E study progress with ACI Pharma
∎ Provide Technical assistance to ACI in Dossier review and BE study.
∎ Arrange and coordinate meetings with DGDA, NCL, NTP and other stakeholder.
∎ Submit weekly, by weekly and monthly progress reports to USP PQM+ program & USAID.
∎ Any other activities are assigned by PQM+ Management.
∎ Training Needs Assessment (TNA) report
∎ GMP training module and Training Report
∎ Coordination meeting minutes with NTP, DHHS and DGDA.
∎ BA/BE study supports.
∎ AOB
Additional Requirements:
∎ Minimum 6 (six) years of experience
∎ Good relationships/network with key clinical laboratory stakeholders across Bangladesh
∎ Education and Experience in working in the field of public health.
∎ Have understanding with NRA functions.
∎ Good understanding about TB medicine and medicine quality is a privilege.
∎ Experience in working with USAID-funded programs.
∎ 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 and NTP regulatory functions
∎ Excellent technical writing skills, experience with gap analyses
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 22 May 2021
Company Information:
∎ 17 May 2021
∎ 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: Medical/Pharma
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