USP’s Global Health and Manufacturing Services (GHMS) department supports multiple countries in southeast Asia to build the capacity of their Medical Product National Quality Control Laboratories (NQCLs). In addition to strengthening the technical capacity of the NQCLs and implementing robust quality management systems towards achieving international accreditation, GHMS is working to expand their testing capabilities in microbiology and COVID-19 related products to address current global health challenges with ensuring quality-assured products.
Scope of Work
In Cambodia and Laos, the Australian Department of Foreign Affairs and Trade (DFAT) has contracted USP to strengthen the NQCLs in both countries towards achievement of ISO 17025 accreditation and WHO prequalification. In addition, DFAT has recently provided USP additional funding to support NQCL requested assistance in two more areas: 1) technical assistance to conduct quality control testing on COVID related PPE commodities, including gloves, face masks, lab coats, alcohol gels, and others, and 2) assessing readiness of microbiology laboratory against ISO 15189 criteria and developing an institutional development plan (IDP) to guide future assistance in obtaining this accreditation.
Therefore, USP seeks a subject matter expert to complete technical assistance activities to strengthen NQCLs’ capability to conduct QC testing for COVID PPE commodities and assess microbiology laboratory readiness against ISO 15189 requirements for accreditation. He/she will lead in conducting a gap assessment and (IDP) development to identify opportunities and areas for support going forward. The NQCL ultimate goal for their microbiology laboratories, beyond the scope of this activity, is to obtain accreditation and WHO PQ status to allow for in-country testing of COVID and other vaccines. This activity is the first step in identifying the steps and roadmap for achieving intermediate milestones along that path.
The consultant/vendor will work within a dynamic, fast-paced environment. The consultant/ vendor will liaise with staff from each NQCL, and GHMS staff and consultants to implement the activities, ensuring high-quality project deliverables in compliance with all USP and donor requirements.
The period of performance for this consultancy will begin August 1, 2022, and end May 30, 2023
Key Responsibilities
· COVID PPE Commodity QA/QC
a. Support NQCLs to define and list key COVID PPE commodities they would like the capability to test in their laboratory
b. Develop COVID PPE commodity training plan and provide relevant product specific TA
· Microbiology laboratory readiness for ISO 15189 and WHO PQ accreditation
a. Conduct gap assessment of the quality management system of the microbiological laboratory and prepare a gap assessment report based on the microbiology lab requirements of WHO prequalification (WHO TRS 961, Annex 2, 2011).
b. Prepare the institutional development plan to build and strengthen the capacity of microbiology laboratory by meeting the requirement in WHO TRS 961 and ISO 15189
· Assist the selected lab staff to prepare CAPA plans and periodically monitor the implementation of the CAPA plans.
· Provide in-country and remote technical assistance across both areas and in developing monitoring strategies for laboratory performance.
Deliverables
· COVID PPE Commodity QA/QC
o Finalized product list
o Training plan
o Training reports
o Trip reports
· Microbiology Laboratory Accreditation Readiness
o Gap assessment report
o Approved IDP
o Trip Reports
· Monthly submission of detailed activity report and other relevant work products as applicable including key deliverables as directed by the program team.
Qualifications
· At least a Master’s degree in microbiology along with relevant training having significant microbiology component and relevant significant professional experience.
· At least five years’ experience working in a microbiological laboratory or related fields.
· Demonstrated ability and aptitude to develop quality management systems and assessing the competence of laboratories conforming to international best practices of ISO 15189, 13485, 17025, 17020
· Knowledge of COVID PPE testing standards and test methods.
· Demonstrated success in engaging and working with multi-disciplinary teams and proven ability in training and mentoring technical staff.
· Excellent oral and written communication skills in English; knowledge of the local language is desired.
· Extensive practical laboratory experience and understandings of laboratory information systems.
Location of Assignment: This assignment will require both remote TA as well as in-country TA in Cambodia and Laos
Please send CV, 3-References, and Hourly Rate to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of July 21, 2022.
When submitting your application, write “PPE and microbiology consultant for Laos and Cambodia” in the email Subject Line.
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. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products
