The Stop TB
Partnership is hiring a Product
Quality Officer who will work under the supervision of the Product Quality Lead to
ensure that TB medicines and diagnostics procured and supplied by GDF to
countries are quality assured and of adequate standard.
The
Product Quality Officer will be responsible of the following activities:
a)
S/he improves
the GDF product quality and regulatory related tools, systems and processes:
-
Identify
QA issues, challenges and risks, and propose innovative solutions and optimal
risk-mitigation measures
-
Develop
and maintain excel/access tool that tracks the availability of valid regulatory
and quality documents for importation of TB medicines and diagnostics, as per
the National Regulatory Authorities requirements
-
Create
a dashboard for rapid tracking and review of product quality and regulatory
documents
-
Maintain
and improve the standardized excel/access tool for systematic review of product
Certificate of Analysis (CoA) vs approved pharmacopeia monographs; provide
brief analysis of the currently available results;
-
Enhance
TB medicines and diagnostics quality complaints management and its recording
and reporting tool.
-
Contribute to analytical work on the
effectiveness and impact of GDF QA policy for TB medicines and diagnostics from
a product and access perspective
-
Ensure availability of QA training, technical
updates, and best practices sharing sessions
b)
S/he stands
as GDF QA responsible person for diagnostics:
-
Review
and update the GDF QA policy for diagnostics
-
Establish the GDF quality monitoring program for
diagnostics
-
Manage and monitor the operationalization and
implementation of the QA policy and quality monitoring program for diagnostics,
including quality testing requirements, selection of quality control agents/laboratories
-
Monitor QA status progress for WHO
recommended diagnostics
-
Act as the quality focal point for GDF diagnostic
tenders
-
Act as focal point for
managing diagnostic quality complaints
-
Work in close collaboration with partners,
including normative agencies such as WHO and regulatory authorities, technical
partners and manufacturers.
-
Work with partners toward harmonization of QA
policy for diagnostics and approaches to respond to countries program needs for
access to quality-assured diagnostics
c)
Assist
with developing the GDF online TB products catalogue.
d)
Review
and maintain up to date the GDF list of quality assurance and quality control (QA/QC)
activities and achievements on the Stop TB /GDF webpage.
e) Perform
other related responsibilities as assigned by GDF Product Quality Lead.