Technical Advisor, QA/QC & Regulatory Systems Strengthening (TA- QA/QC and RSS) 80 views

About USP

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.

Summary of the Position

The Technical Advisor, QA/QC & Regulatory Systems Strengthening (TA- QA/QC and RSS) will have expert skills in two or more regulatory functions including Laboratory quality control/quality assurance, ISO/IEC 17025, market surveillance/control and Vigilance. He/she must understand the medicine regulatory processes from pre-market assessment through market authorization and post-market surveillance. The selected candidate will be responsible for providing specialized technical assistance in the areas of regulatory systems strengthening with a special focus on Laboratory QA/Accreditation, RB-PMS and WHO PQ. He/she will initiate the development of regulations, directives, manuals, guidelines, procedures, and other relevant tools and promotes their proper implementation. As a lead for PQM+ regulatory activities in Ethiopia, the Technical Advisor provides technical oversight related to the program’s objective of improving EFDA’s regulatory systems to assure the quality of medical products in the public and private sectors. Additionally, he/ she acts is a recognized leader, interfacing with the Ethiopian Food and Drug Administration (EFDA) and stakeholders involved in the supply and manufacture of essential medicines.

Roles and Responsibilities

• Facilitate the development of in-house training programs to ensure sustainability and transfer of knowledge within EFDA laboratories.
• Lead accreditation of the branch EFDA laboratories and maintenance of accredited test methods at the main EFDA Laboratory.
• Advises on the interventions to address institutional development plans on the findings of the WHO Global benchmarking assessment related to laboratory testing.
• Leads the roll-out of risk-based post-marketing surveillance and the uptake and application of the MedRS tool
• Provide technical assistance for ISO/IEC 17025:2017 accreditation and/or WHO prequalification by assessing, auditing in preparing and reviewing laboratory processes and procedures
• Assist in preparation of quality control laboratories for WHO inspections, including assistance in strengthening QMS procedures to prepare for WHO inspections, conducting mock audits and preparations of laboratory information files to be submitted to WHO.
• Assist laboratories during WHO inspections and in the development and implementation of CAPA plans
• Provide oversight of local partners and consultants involved in laboratory activities.
• Keep abreast of the latest regulatory trends and WHO guidance
• Actively contribute to the annual programmatic and resource planning process and to the development of quality and annual reports
• Facilitate implementation of RB-PMS in Ethiopia
• Support the EFDA in achieving WHO ML3

Supervisory Responsibilities: None

Benefits

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. GHR Doc 3. Version 5 – 5/Nov/2021 G:\01 Employment\01a Global TA Controlled Documents.

Job Category: Technical Programs

Basic Qualifications

• Bachelor’s degree in pharmacy, Pharmaceutical Science, Chemistry
• Ten (10) years of relative experience leading and providing technical assistance to Medicine quality control laboratories to ensure the availability of quality medical products.

Skills Sought

• Direct experience implementing USAID-funded programs
• Working knowledge and understanding of regulatory systems strengthening in Ethiopia with an emphasis on Quality Assurance/Quality Control of medical products.
• Strong written (especially technical writing) and oral communication skills
• Willingness to travel at least 25% of the time

Preferred Qualifications

• Five years of people management experience and skills
• Direct experience with an understanding of WHO global benchmarking tool
• Experience in at least one of the following health areas: HIV/AIDS, Malaria, TB, NTDs, AMR, MNCH

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

Education Required

• Bachelors or better in Chemistry/Pharmacy