Consultant for IEDCR
Job Description
Title: Consultant for IEDCR
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Contractual
Educational Requirements:
∎ Master's degree in Microbiology/Virology or related field of study.
Job Context:
∎ The Promoting the Quality of Medicines Plus (PQM+) Program, a Cooperative Agreement between the United States Agency for International Development (USAID) and the United States Pharmacopeia (USP), strengthens medical product quality assurance systems in low- and middle-income countries through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. PQM+ looking for a consultant with expertise and experience in the following technical areas. The consultant will work with the Institute of Epidemiology Disease Control and Research (IEDCR) scientists and management to provide technical assistance to build their capacity for laboratory testing in Bangladesh. S/he will engage in providing technical support to the IEDCR laboratory to achieve international standards toward accreditation (ISO 15189 & 15190).
∎ Work Station: IEDCR (60%) and USP Office (40%)
∎ Position Type:
∎ Full-time Consultant
∎ Time period: till September 2023 (with Possible Extension)
∎ Job Category: Global Public Health and Manufacturing Services
Job Responsibilities:
∎ Provide technical support to IEDCR and PQM+ teams on lab functions and increase the laboratory's capacity to achieve and maintain ISO standards.
∎ Conduct Gap assessment, develop Corrective and Preventive Actions(CAPAS), and capacity building to address CAPAS.
∎ Train the selected medical labs, on how the standard is used in assessing the competence of medical laboratories.
∎ Technical support for ensuring laboratory biosafety and biosecurity.
∎ Provide training to the selected medical labs on detailed demonstration of ISO 15189 accreditation process by any internationally recognized accreditation body.
∎ Arrange awareness sessions on ISO 15189 and 15190 standards for selected medical labs.
∎ Conduct training as per needs and prepare training reports on PQM+ reporting format.
∎ Develop/review policies, regulations, guidelines, and SOP's related to ISO requirements.
∎ Keep abreast of the latest regulatory trends and WHO guidance with regard to the lab.
∎ Develop/Review and update protocol, and implement instrument and test-related procedures.
∎ Collect and interpret quantitative/qualitative information, with analytical problem-solving.
∎ Organize and support SOPs management systems in the selected medical labs to achieve ISO 15189 accreditation.
∎ Provide support to the selected medical labs for developing documents according to standard requirements.
∎ Conduct hands-on training on PCR system, Incubator, Bio-safety Cabinet, size exclusion chromatography, inverted microscope, flow cytometry, different blotting techniques, etc.
∎ Prepare the cell bank through cell revival, sub-culture, and cryopreservation of different cell lines.
∎ Collaborate with IEDCR management, PQM+ country team, PQM+ HQ Technical Team and other implementing partners and stakeholders.
∎ Prepare monthly and quarterly reports for USP and USAID.
Additional Requirements:
∎ Minimum 10 (Ten) years of practical experience in a reputed medical laboratory or in a Microbiology laboratory of any leading pharmaceutical.
∎ Good knowledge and understanding of medical laboratory regulatory systems strengthening.
∎ Familiar with cGLP, QMS, and internal audit systems.
∎ Should have proper knowledge of the ISO 15189 standard and have the training or auditor certification on this standard from a recognized accreditation body.
∎ Should have extensive knowledge of biosafety and biosecurity.
∎ Demonstrated ability in developing policies, regulations, and guidelines related to ISO requirements.
∎ Demonstrated ability to lead professionals and manage others through influence and collaboration.
∎ Demonstrated ability to collect and interpret quantitative/qualitative information, with analytical problem-solving.
∎ Preferred qualifications:
∎
∎ Working knowledge and understanding of regulatory systems strengthening in Bangladesh with an emphasis on Quality Assurance/Quality Control of medical lab.
∎ Highly desirable: Working experience with laboratory activities, medical equipments and biosafety in laboratory.
∎ Skills: Logical and analytical capabilities and comfort with handling data; very strong communication skills including the ability to write in English clearly and concisely; ability to work effectively across a broad range of stakeholders and administrative levels; project management.
∎ Willing: Handle multiple tasks and be flexible to respond to changing needs and travel.
∎ Preferred Competency:
∎
∎ USP Acumen : Can explain USP's mission, organization, and strategy in the context of the role, as well as policies, practices, and trends, impacting USP and its stakeholders.
∎ Interpersonal Savvy : The ability to apply varying social skills across diverse situations to increase impact with people of different backgrounds and styles.
∎ Relationship Building : Regularly invests time in initiating and sustaining relationships with colleagues and external stakeholders to drive results
∎ Influencing Others : Able to communicate a unique individual perspective in a way that impacts others' thinking.
∎ Innovation : Motivated to incorporate new ideas and thinking into everyday problems.
∎ Results Orientation : Consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy.
∎ Developing Others : Places value in helping colleagues to grow by sharing knowledge, actionable feedback, and new insights regularly.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 7 Nov 2022
Company Information:
∎ 25 Oct 2022
∎ 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
