USP seeks a Pharmaceutical Quality Control Laboratory Quality Management Systems consultant to provide
support to the Cure TB 2 program in Kyrgyzstan. The consultant should have
expert knowledge of quality principles and practices to the design, implementation,
control, monitoring, assessment, and continuous improvement of work processes.
S/he will provide technical assistance based upon expertise and knowledge of
evidence-based methods and strategies, current practice, and established
laboratory and operational standards. S/he will work within a dynamic,
fast-paced environment and is responsible for providing day-to-day technical
program implementation support for a multi-project portfolio. S/he will liaise with national counterparts
and USP staff to provide technical support to the JSI Cure TB2 project,
ensuring the development of high-quality project deliverables and compliance
with all USP and donor requirements.
Key Responsibilities
• Work closely with the Program Manager and local team
to provide technical program implementation support for Cure TB 2 project.
• Provide technical assistance by assessing and reviewing Quality Management
System (QMS) of the laboratory against
WHO prequalification standards.
• Provide technical assistance to develop Corrective
and Preventive Action (CAPA) plan to ensure compliance with WHO pre-qualification
requirements.
• Conduct facility inspections to ensure
environmental, equipment and staffing capabilities, which will be applied to
corrective and preventive actions.
• Provide technical assistance in implementation
of CAPA plan.
• Review and provide comments on the Laboratory
Information File (LIF) prepared by the laboratory. Help track data to support
quality metric reports ensuring laboratory compliance and follow-up through
continual improvement.
• Provide training to the staff of the
laboratories in the specific areas as needs are identified (e.g., good
laboratory practice, analytical methods).
• Prepare and
submit technical assessments and travel
reports in timely manner
Qualifications
Education
· Bachelor’s degree in science, pharmaceutical sciences, chemistry, or
related discipline, or equivalent combination of education and relevant quality
assurance experience in a regulated industry (pharmaceutical, biotech, or
similar).
Professional Experience
· Minimum of 10 years of quality assurance (QA) experience in the
pharmaceutical industry.
· Extensive experience in auditing quality control (QC) laboratories
· Strong pharmaceutical background with demonstrated expertise in QA/QC of
pharmaceuticals.
· Previous experience with programs aimed at strengthening medicines
quality assurance systems is preferred.
· Prior work experience in Central Asia is an asset.
Technical Expertise
· Solid knowledge of QA/QC processes in the pharmaceutical industry.
· Excellent understanding of ISO/IEC 17025 requirements and WHO
prequalification standards for medicines quality control laboratories.
· Demonstrated skills in audit planning, lead auditing techniques, and
corrective action implementation.
· Proven experience in designing and delivering training programs on Good
Laboratory Practices (GLP) for laboratory staff.
Communication & Interpersonal Skills
· Ability to simplify and clearly explain complex technical information to
diverse audiences.
· Strong facilitation and mentoring skills, with capacity to build local
laboratory staff competencies.
· Excellent writing skills, with ability to produce clear project
documentation, training materials, reports, and stakeholder communications.
· Professional, articulate, and able to communicate effectively with key
internal/external stakeholders.
· Ability to work independently as well as collaboratively with cross-cultural
and cross-functional teams.
· Knowledge of Russian is preferred.
Other Requirements
· Willingness to travel within Central Asia for laboratory assessments,
training, and stakeholder engagement.
Deliverables
• Gap analyses report
• Training report
• Technical reports
• Trip reports
• Meeting notes
• SOPs, guidelines
• Others as applicable
Application Procedure Please send your CV, Cover Letter, 3 References,
and hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date of December
19, 2025. When submitting your applications, please write “TA QMS Kyrgyzstan” in
the email Subject Line of your email.
USP is an independent scientific organization that collaborates with the world's top experts in health and
science to develop quality resources and standards for medicines, dietary
supplements, and food ingredients. Through our resources, standards, advocacy
and education, USP helps increase the availability of quality medicines,
supplements and foods for billions of people worldwide. Our programs have
reached more than 90 countries across Africa, Asia, and North and South America
to strengthen global supply chains and pharmaceutical ecosystems that enable a
resilient supply of quality medical products.
The USG Cure Tuberculosis 2 (Cure
TB 2) project led by JSI Research and Training Institute, Inc. (JSI) in the
Kyrgyz Republic aims to transform TB care, making it more people-centered, and
reducing the burden of TB on the people and economy of the Kyrgyz Republic.
Building on the successes of the previous USG Cure TB project, Cure TB 2
collaborates with national partners, including the Ministry of Health (MOH) and
the National TB Program (NTP), to implement comprehensive TB prevention and
care reforms nationwide. As a partner to JSI to support the aims of this
project, USP will collaborate with JSI to provide technical assistance to
strengthen TB diagnostic laboratory testing and further improve the quality and
accuracy of TB diagnostic services and ensuring adherence to international
standards such as ISO accreditation. USP will also implement activities to
support improving the procurement and supply chain management for TB drugs in
the country., including medicines quality assurance activities. For this purpose,
USP will provide technical assistance to Medicines Quality Control Laboratory
of Department of medicines and Medical Devises under the Ministry of Health of
Kyrgyzstan.
