International PAHO Consultant - Development of NIP Quality Management Tools

Organizational Context

The Pan American Health Organization (PAHO) serves as the Regional Office for the Americas of the World Health Organization (WHO).

Job Purpose

To develop tools and a regional manual to guide countries in the Americas in implementing procedures for managing nonconformities and incidents related to vaccine safety risks and vaccination processes.

Responsibilities

Define methodology for identifying and analyzing information sources on National Immunization Programs' (NIPs) capacity to manage nonconformities. Define indicators for NIPs' capacity to manage nonconformities and implement corrective and preventive actions (CAPA). Design and conduct a rapid assessment/survey on the implementation of nonconformity and corrective action procedures. Prepare a situational analysis report on the management of temperature deviations and programming errors. Review international frameworks (ISO 9001/9000) applicable to vaccine management and the vaccination process. Define the structure and draft a Regional Manual for the Management of Nonconformities and Incidents for NIPs, including practical tools. Conduct technical validation of the manual and tools with stakeholders and prepare a proposal for adjustments. Formulate a methodological proposal for a national adaptation proof-of-concept study in two pilot countries.

Work Experience

Minimum of 5 years of experience in evaluating, designing, or implementing quality management systems (QMS) or health risk management systems. Experience in planning and implementing nonconformity procedures and corrective/preventive actions (CAPA), including indicators and follow-up. Experience in investigating and managing events related to the quality/safety of health products or services (e.g., program errors, cold chain, adverse events linked to process failures). Experience with quality processes and management in National Immunization Programs is preferred. Experience in managing nonconformities related to the vaccine cold chain/supply chain, root cause analysis, internal audits, and continuous improvement is preferred.

Skills

Quality Management Systems, Health Risk Management, Nonconformity Management, Corrective and Preventive Actions (CAPA), Root Cause Analysis, Vaccine Management, Cold Chain Management, Public Health, Data Analysis, Report Writing, Stakeholder Engagement.

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