Quality Management Systems Consultant
USP seeks consultants/vendors with expertise in one or more of the technical areas of interest below to be shortlisted for a candidate pool for potential future work in various countries throughout the Africa, Asia, and Central Asia regions. Note that this is a general Call for Consultants to build a qualified applicant pool. This job posting does not guarantee employment. Consultants and firms who meet the outlined qualifications and skills listed below will be added to the USP Consultant Database for future potential engagement. Those selected to be added to the Consultant Database will be notified. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division. Applications may be made to one or more of the technical areas of interest, based on the consultant’s/vendor’s qualifications. Note that this is a remote role with possibility for travel. This is a global position and candidates worldwide are encouraged to apply. Note that this may be a remote position with possibility of travel.
Roles and Responsibilities
Develops training materials and facilitator’s guides for defined QMS training
Provides TA in development and implementation of Laboratory QMS (LQMS)
Develops pre and post-test questions for defined laboratory QMS training
Delivers defined QMS training and evaluates the performance of the trainees
Provide TA in conducting internal quality audit, management of CAPA and prepare the lab for external accreditation assessment
Provides supportive assistance for Laboratory QMS implementation
Provides mentorship/coaching to NQCL’s Quality Assurance team
Conducts laboratory assessments using the Stepwise Assessment Tool Towards Accreditation (SATTA) and other assessment tools like SLIPTA
Implements the Laboratory Programs Unit’s Laboratory systems strengthening approach
Provides technical support to MRAs on Laboratory Testing and access (LA) function to reach at least WHO GBT Maturity Level 3.
Serves as a technical resource among the GPH technical Laboratory System Strengthening (LSS) staff with respect to Laboratory QMS activities.
Participates in the development of in-house training programs to ensure sustainability and transfer of knowledge.
Provides inputs in the development of GPH technical approach tools.
Performs other assignments as requested by the Senior Technical Advisor, LSS, the Senior Technical Director and program manager for West Africa/.
Writing of Technical and trip reports.
Basic Qualifications
Eight (8) years’ experience in pharmaceutical regulation, regulatory functions and particularly in Pharmaceutical laboratory QMS (LQMS).
Solid knowledge and understanding of the norms and practices of pharmaceutical systems in Africa
Master’s degree in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field.
Skills Sought
Strong written (especially technical writing) and oral communication skills in either French or Portuguese and English.
Hands on experience in establishing and implementing Quality Management Systems at country and regional levels.
Well versed in the following standards: ISO/IEC 17025:2017, ISO 9001:2015, ISO 15189:2012and WHO Good Practices for Pharmaceutical Quality Control Laboratories
Direct experience with and understanding of WHO global benchmarking tool and other Lab QMS assessment tools.
Willingness to travel at least 25% of the time.
Preferred Qualifications
Demonstrated experience working in key functions in an MRA or organization providing technical assistance to strengthen medicines quality assurance systems.
Direct experience implementing USAID-funded programs.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to gph_procurement@usp.org by the 03/26/2024. When submitting your application, write “Call for QMS Consultant” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
