The U.S. Pharmacopeial Convention (USP) Senior Technical Officer PQMPlus - Medical Devices in Kebele 01/02, Ethiopia
Summary of the Position
The Senior Technical Officer, Medical Devices is a non-supervisory role reporting to the Chief of Party (Cop)-Ethiopia of the Promoting the Quality of Medicines Plus (PQM+) program within the Global Health and Manufacturing Services Division. The incumbent in this role liaises and collaborates with country technical advisors, regional technical officers, project managers and chief to ensure the successful implementation of program objectives. s/he will provide technical expertise and guidance to designated activities in Ethiopian PQM+ portfolio in the areas of quality management of medical devices and metrology. The incumbent is expected to develop, operationalize, and improve performance of cold chain equipment in the country through equipment preventative maintenance and calibration programs to ensure compliance with international standards and guidelines. Additionally, s/he will apply knowledge of laboratory Quality Management System (LQMS) and measurement science to create and deliver training on instrument/equipment qualification, calibration, and preventative maintenance as well as general quality processes.
Roles and Responsibilities
Assist the Ethiopian Public Health Institute (EPHI) to comply with equipment requirements defined in international standards and guidelines: to include ISO/IEC 17025 so that the Institute will have an internal metrology unit.
Develop and evaluate cold chain equipment corrective , preventative maintenance and calibration programs to determine strengths and areas for potential improvement.
Develop guideline and protocol for repair and maintenance system of cold chain equipment
Develop cold chain temperature monitoring and managing cold chain problems protocol
Prepare development plans to address gaps in staff involved on immunization facilities against Good Distribution Practice (GDP),Good Storage Practice (GSP) and Good documentation practice (GDP) requirements for cold chain equipment and processes
Develop calibration procedures and methods, according to detailed specifications, and manufacturers requirement
Provide technical support for calibration of cold chain equipment ai immunization centers
Analyze measurement data to identify irregularities, trends and/or to predict future values
Develop and deliver technical scientific training courses according to the needs of the different laboratories; pharmaceuticals, biopharmaceuticals, and clinical/medical
Assist with standard operating procedure optimization
Work withy Ethiopian National Metrology Institute (ENMI) to train staff of EPHI and health workers at the immunization facilities on basics of Metrology
Collaborate with ENMI to calibrate cold chain equipment at immunization facilities.
Bsc in Metrology/Physics/Biomedical engineer/ Chemistry, or related field, with a minimum of 8-years’ experience in calibrating, operating and maintaining medical equipment like cold chain equipment including refrigerators, thermometers etc…
Three years’ experience with calibration of equipment used in the pharmaceutical supply system, medical device, and medicine laboratories.
Three years interfacing with internal or external clients or stakeholders
At least one year demonstrated knowledge of ISO 9001 and ISO/IEC 17025:2017.
Experience developing and/or conducting training with special focus on Metrology
Working knowledge and understanding of equipment verification, calibration and maintenance.
Requires excellent written and verbal communication skills and the ability to communicate science/technical information to those without a background in science.
Familiar with and demonstrates knowledge of GXP/GLP and the importance of measurement Uncertainty (MU)
Deep domain knowledge and understanding of analytical concepts, principles, and theories related to chemical and Mechanical testing
Strong ability to troubleshoot and problem solve and assess risks associated with a decision
Ability and desire to influence without direct authority as well as work well with diverse employees and customers in a cooperative and friendly manner
Ability and willing to travel 25%-30% locally.
Three years hands on experience on Metrology.
Prior experience in a government funded programs, such as USAID.
Intermediate computer skills: office, excel, PowerPoint, SharePoint
Results driven with demonstrated successful outcomes.
Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
Demonstrated experience designing project and developing technical components of proposals for donor funded programs (i.e.: USAID, GFATM, Gates Foundation, UNITAID, WHO, etc.).
Experience working internationally for a global health organization in low- and middle-income countries.
Qualifications Behaviors Required
Leader: Inspires teammates to follow them
Innovative: Consistently introduces new ideas and demonstrates original thinking
Dedicated : Devoted to a task or purpose with loyalty or integrity
Team Player: Works well as a member of a group
Functional Expert: Considered a thought leader on a subject
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Technical Programs
Job Type Full-Time