Technical Advisor, Quality Assurance/Quality Control (QA/QC)

Technical Advisor, Quality Assurance/Quality Control (QA/QC)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that 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.

The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.

USP is seeking for a Technical Advisor, Quality Assurance/Quality Control (QA/QC) in support of PQM+ program implementation in Nepal.

Under the guidance of the Chief of Party, the Technical Advisor, QA/QC will lead the implementation of quality assurance and quality control technical assistance support to the Department of Drug Administration (DDA) and private sector quality control laboratories towards sustainable quality control capacity building  to ensure that medical products circulating in Nepal are safe, efficacious and meets the relevant international and local standards. S/he will oversee to the overall quality implementation of the laboratory components of the PQM+ in Nepal’s work plan.  The Technical Advisor is expected to extensively liaise and collaboratively work with key technical stakeholders, including but not limited to, Ministry of Health, Department of Drug Administration (DDA) , National Medicines Laboratory (NML), World Health Organization (WHO), etc. and to represent PQM+ in technical working groups, technical forums and conferences to advance PQM+ thought leadership in laboratory QA/QC. 

The Technical Advisor, QA/QC will work his/her technical counterparts in PQM+ Nepal, including Technical Advisor, Regulatory Systems (RSS), Technical Advisor, Chemistry, Manufacturing and Control (CMC), as well as with PQM+ Headquarters Technical Directors, to develop annual work plan, implementation plan and monitoring, evaluation and learning (MEL) to successfully execute PQM+’s strategy in Nepal. The Technical Advisor QA/QC must possess advanced knowledge of pharmaceutical laboratory quality management systems processes and procedures including hand-on technical experience in instrumental techniques – HPLC, UV/Vis, AAS, GC and FTIR – and good documentation practices, data integrity, SOP development, internal audits etc. He/she must have exposure to ISO 17025 or WHO PQ laboratory environment in either national quality control laboratory or pharmaceutical manufacturing and control laboratory.   

Roles and Responsibilities

• Lead the technical QA/QC implementation of PQM+ annual work plans by conducting technical trainings in laboratory quality management systems, instrumental techniques and good documentation practices 
• In consultation with PQM+ technical director, oversee the development of laboratory technical strategy for Nepal and work with in-country partners to successfully execute this strategy
• Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge within public and private laboratories
• Advises on the interventions to address institutional development plans based on the findings of the WHO Global benchmarking assessment related to laboratory testing
• Supports the roll-out of risk-based post marketing surveillance and the uptake and application of the MedRStool
• Provide technical assistance for ISO 17025 accreditation and/or WHO prequalification by assessing, auditing, 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 of mock audits and preparation of laboratory information files to be submitted to WHO.
• Assist laboratories during WHO and Accreditation Body (AB) inspections and in the development and implementation of corrective action and preventive (CAPA) plans
• Provide oversight of local and regional partners and consultants involved in laboratory activities
• May manage and mentor junior technical staff
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports

Basic Qualifications

• Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required. Minimum of 10 years of relative experience in pharmaceutical quality control testing with public or private laboratories 
• Working knowledge and understanding of regulatory systems strengthening in Nepal with an emphasis on Quality Assurance/Quality Control of medical products
• Strong written (especially technical writing) and oral communication skills in English
• Willingness to in-country travel at least 25% of the time.

Preferred Qualifications

• Direct experience implementing USAID-funded programs
• Direct experience with and understanding of WHO Prequalification and or ISO 17025 for testing and calibration laboratories
• Experience in at least one of the following health areas: HIV/AIDS, malaria, TB, NTDs, AMR, MNCH

Supervisory Responsibilities

• Non-supervisory position 

Application Process:

Interested candidates should submit cover letter, CV, and USAID Form 1420 (available at https://www.usaid.gov/forms/aid-1420-17) by email to GPHNepalRecruitment@USP.org clearly stating Technical Advisor Quality Assurance/Quality  Control (QA/QC) in the subject line of the e-mail.

Application Deadline: August 30, 2020