USP
seeks Quality Assurance & Quality Control (QA/QC) Consultant with expertise
in quality control of Medical Devices (eg rapid diagnostic test kits, condoms,
surgical gloves ) for a potential 3-year project in DRC, where USP will provide
assistance towards strengthening the maturity level of the National
Pharmaceutical Regulatory Authority (ACOREP), strengthening capacities of the
National Quality Control Laboratory, and developing strategy to strengthen
local production of medicines and vaccines. The expert should have a strong
background in establishing and implementing QMS for medical devices
laboratories and in building capacity for QC testing of medical devices within
quality control laboratories at country and regional levels. The expert should
have proven ability to deliver training, provide technical assistance, conduct
assessments, and mentor QC teams. The position requires solid knowledge of ISO
13485, ISO 17025 standards and WHO good practices, as well as demonstrated
experience in strengthening medicines QA/QC systems through technical
assistance and donor-funded programs.
**This
opportunity is connected to a proposal. Any consultant engagement is contingent
upon contract award.**
Roles
and Responsibilities
Potential tasks that the consultant/vendor will be
responsible for carrying out include:
· Developing training materials and facilitator’s guides for
defined medical devices QC training.
· Developing pre- and post-test questions for defined medical
devices laboratory QC training.
· Delivering defined medical devices QC training and
evaluating the performance of the trainees.
· Providing technical assistance to NQCLs to implement QMS
(e.g., ISO 17025, 13485) and WHO Good Practices.
· Providing mentorship and coaching to NQCL QA/QC teams.
· Conducting laboratory assessments using the Stepwise
Assessment Tool Towards Accreditation (SATTA).
· Implementing the laboratory program unit’s laboratory
systems strengthening approach.
· Providing technical support to NRAs on laboratory testing
and national regulatory systems functions to reach WHO GBT Maturity Level 3.
· Serving as a technical resource among USP technical RSS
staff on laboratory medical devices activities.
· Participating in the development of in-house training
programs to ensure sustainability and transfer of knowledge.
· Providing inputs in the development of USP technical
approach tools.
· Preparing technical and trip reports.
Qualifications
· Masters degree in microbiology, chemistry, biomedical
sciences or other relevant science degree.
· Eight (8) years’ experience in quality control testing as
per pharmacopeial standards, specifically for medical devices (eg rapid
diagnostic test kits, condoms, surgical gloves)
· Ability to travel for up to 25% of the time (if applicable)
· Excellent written and oral communication skills, including
experience in training and mentoring staff and others
· Strong written (especially technical writing) and oral
communication skills in both English and French.
· Resides in the Africa Region (Please specify countries of
experience)
· Solid knowledge and understanding of the norms and practices
of pharmaceutical systems in Africa
· Knowledge of and experience with: Pharmaceutical systems in Africa, ISO 13485 ISO/IEC 17025:2017 and
WHO Good Practices for Pharmaceutical Quality Control Laboratories, WHO Global
Benchmarking Tool and other laboratory QMS assessment tools.
Preferred Qualifications
· Resides in the Africa Region (Please specify countries of
experience)
· Demonstrated experience working in microbiology quality
control testing within an NQCL or a private QC laboratory that conducts quality
control testing of medical devices .
· Direct experience implementing donor-funded programs
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 12, 2025. When submitting your applications, please
write “QA/QC – Medical Devices” in the email Subject Line of your email.
The U.S.
Pharmacopeial Convention (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. USP’s Global Health 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.
