Product Quality Assurance Officer

DESCRIPTION

The Partnership for Supply Chain Management (PFSCM) strengthens, develops, and manages secure, reliable, cost-effective, and sustainable global supply chains to improve the health and well-being of people in low- and middle-income countries through increased access to quality and affordable health products. We help governments, non-profit organizations, and humanitarian agencies to achieve their public health goals through cost-saving procurement, efficient logistics, pharma-grade storage, last-mile delivery solutions, and real-time data tracking. PFSCM demonstrates its commitment to customer satisfaction and service excellence by upholding an ISO 9001:2015 certified Quality Management System that underpins all our processes, systems, and services.
PFSCM is a subsidiary of one of the leading international health consultancy organizations in the US — JSI Research & Training Institute, Inc. (JSI). In addition to our project management headquarters in Washington D.C., in the U.S., and our operational facility in Woerden, in the Netherlands, we have access to 50 other JSI offices around the world.
Within PFSCM’s global structure, approximately 115 seconded staff members from more than 45 countries contribute to the impact achieved through PFSCM’s services. PFSCM’s diversity of thought and culture allows us to engage fully with our clients and each other. We believe we can achieve our mission by upholding our purpose- and results-driven cultural style. We do this by creating an environment where staff can demonstrate our cultural values of collaboration, learning, proactivity, problem solving, and outcome orientation on a daily basis.

RESPONSIBILITIES

The Product Quality Assurance (QA) Officer is responsible to ensure quality compliance in all PFSCM projects. The Product QA Officer is expected to ensure that all product and manufacturer-related documentation align with the quality requirements set forth in the relevant policies by participating in product dossier review process. The Product QA Officer will ensure alignment between the Global Fund’s list of eligible diagnostics (COVID-19, HIV/AIDS, TB & Malaria) and PFSCM’s item master.
The Product QA Officer is also expected to support the QA and Regulatory Manager and work closely with multiple units across PFSCM and members of the Quality Management Unit.
Specific responsibilities

• Manage and maintain product dossiers or technical documentation submitted as part of PFSCM’s product prequalification process.
• Support operational units in defining product eligibility and quality requirements and corresponding QA documentation, specifically for medical devices and diagnostics.
• Liaise with Strategic Supply Chain and Client Service Units to ensure completeness and accuracy of product dossiers received from vendors, as part of RFQ/RFP process.
• Compile and complete initial screening of product dossiers to make any required recommendations for their approval to the QA and Regulatory Manager.
• Ensure proper filing, access, and retrieval of product dossiers and records related to QA decisions.
• Track the Global Fund’s eligible list of diagnostics on a weekly basis and coordinate with the Product QA Data Officer to ensure that only approved products are maintained in PFSCM item master in the ERP system.
• Centralize product QA requirements in a relevant tool/platform to serve as a quick reference for operational units.
• Collaborate with Strategic Sourcing to streamline catalogue management by contributing insights from medical devices and diagnostics regulations.
• Monitor field safety notices (FSN) and field safety corrective actions (FSCA) issued by manufacturers and liaise with suppliers and internal units to ensure required actions are completed.
• Support Logistics and 4PL Units in shipment planning and ensuring compliance with local regulatory requirements by providing insights on product characteristics, stability profile and storage requirements.
• Summarize and verify shipment/data logger reports under the supervision of the QA and Regulatory Manager, notify Logistics Unit on the disposition of the delivered goods.
• Support QA-related incidents by gathering information, providing input for investigation and contributing to the resolution.
• Support QMU by preparing reports on incidents that communicate status, trends and outstanding actions for management review, project management, and KPI reporting to the client.
• Support drafting of reports (product recall reports, PPM QA metrics and others) for submission to the Global fund and other PFSCM Clients.
• Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions in line with PFSCM’s Quality Management System.

QUALIFICATIONS

• Bachelor’s degree in Healthcare and Life Sciences or other relevant field.
• 3+ years’ work experience in quality assurance/regulatory affairs in a medical device & diagnostics industry, healthcare organization.
• Knowledge about Good Manufacturing Practices, Good Distribution Practices, ISO 13485, and other relevant standards.
• Understanding of the medical device & diagnostics regulatory environment both at international and country level.
• Knowledge of the international health products market with specific reference to essential diagnostics required for COVID-19, HIV/AIDS, Tuberculosis, and Malaria.
• Strong interpersonal skills and an ability to work across disciplines and in diverse locations internationally.
• Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint. Advanced user level of Excel preferred.
• Excellent written/verbal communication and interpersonal skills with strong sense of customer service. English fluency required, including speaking, writing, understanding, and reading.
• Demonstrated analytical skills; solution oriented with a high sense of quality, attention to detail, accuracy, efficiency, and meeting tight deadlines.
• Team player who is also able to work independently and handle conflicting priorities while maintaining consistent, quality performance standards.
• Willingness and availability to travel, and perform other duties as needed.
• Must be authorized to work in the Netherlands.

DESCRIPTION

The Partnership for Supply Chain Management (PFSCM) strengthens, develops, and manages secure, reliable, cost-effective, and sustainable global supply chains to improve the health and well-being of people in low- and middle-income countries through increased access to quality and affordable health products. We help governments, non-profit organizations, and humanitarian agencies to achieve their public health goals through cost-saving procurement, efficient logistics, pharma-grade storage, last-mile delivery solutions, and real-time data tracking. PFSCM demonstrates its commitment to customer satisfaction and service excellence by upholding an ISO 9001:2015 certified Quality Management System that underpins all our processes, systems, and services.
PFSCM is a subsidiary of one of the leading international health consultancy organizations in the US — JSI Research & Training Institute, Inc. (JSI). In addition to our project management headquarters in Washington D.C., in the U.S., and our operational facility in Woerden, in the Netherlands, we have access to 50 other JSI offices around the world.
Within PFSCM’s global structure, approximately 115 seconded staff members from more than 45 countries contribute to the impact achieved through PFSCM’s services. PFSCM’s diversity of thought and culture allows us to engage fully with our clients and each other. We believe we can achieve our mission by upholding our purpose- and results-driven cultural style. We do this by creating an environment where staff can demonstrate our cultural values of collaboration, learning, proactivity, problem solving, and outcome orientation on a daily basis.

RESPONSIBILITIES

The Product Quality Assurance (QA) Officer is responsible to ensure quality compliance in all PFSCM projects. The Product QA Officer is expected to ensure that all product and manufacturer-related documentation align with the quality requirements set forth in the relevant policies by participating in product dossier review process. The Product QA Officer will ensure alignment between the Global Fund’s list of eligible diagnostics (COVID-19, HIV/AIDS, TB & Malaria) and PFSCM’s item master.
The Product QA Officer is also expected to support the QA and Regulatory Manager and work closely with multiple units across PFSCM and members of the Quality Management Unit.
Specific responsibilities

• Manage and maintain product dossiers or technical documentation submitted as part of PFSCM’s product prequalification process.
• Support operational units in defining product eligibility and quality requirements and corresponding QA documentation, specifically for medical devices and diagnostics.
• Liaise with Strategic Supply Chain and Client Service Units to ensure completeness and accuracy of product dossiers received from vendors, as part of RFQ/RFP process.
• Compile and complete initial screening of product dossiers to make any required recommendations for their approval to the QA and Regulatory Manager.
• Ensure proper filing, access, and retrieval of product dossiers and records related to QA decisions.
• Track the Global Fund’s eligible list of diagnostics on a weekly basis and coordinate with the Product QA Data Officer to ensure that only approved products are maintained in PFSCM item master in the ERP system.
• Centralize product QA requirements in a relevant tool/platform to serve as a quick reference for operational units.
• Collaborate with Strategic Sourcing to streamline catalogue management by contributing insights from medical devices and diagnostics regulations.
• Monitor field safety notices (FSN) and field safety corrective actions (FSCA) issued by manufacturers and liaise with suppliers and internal units to ensure required actions are completed.
• Support Logistics and 4PL Units in shipment planning and ensuring compliance with local regulatory requirements by providing insights on product characteristics, stability profile and storage requirements.
• Summarize and verify shipment/data logger reports under the supervision of the QA and Regulatory Manager, notify Logistics Unit on the disposition of the delivered goods.
• Support QA-related incidents by gathering information, providing input for investigation and contributing to the resolution.
• Support QMU by preparing reports on incidents that communicate status, trends and outstanding actions for management review, project management, and KPI reporting to the client.
• Support drafting of reports (product recall reports, PPM QA metrics and others) for submission to the Global fund and other PFSCM Clients.
• Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions in line with PFSCM’s Quality Management System.

QUALIFICATIONS

• Bachelor’s degree in Healthcare and Life Sciences or other relevant field.
• 3+ years’ work experience in quality assurance/regulatory affairs in a medical device & diagnostics industry, healthcare organization.
• Knowledge about Good Manufacturing Practices, Good Distribution Practices, ISO 13485, and other relevant standards.
• Understanding of the medical device & diagnostics regulatory environment both at international and country level.
• Knowledge of the international health products market with specific reference to essential diagnostics required for COVID-19, HIV/AIDS, Tuberculosis, and Malaria.
• Strong interpersonal skills and an ability to work across disciplines and in diverse locations internationally.
• Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint. Advanced user level of Excel preferred.
• Excellent written/verbal communication and interpersonal skills with strong sense of customer service. English fluency required, including speaking, writing, understanding, and reading.
• Demonstrated analytical skills; solution oriented with a high sense of quality, attention to detail, accuracy, efficiency, and meeting tight deadlines.
• Team player who is also able to work independently and handle conflicting priorities while maintaining consistent, quality performance standards.
• Willingness and availability to travel, and perform other duties as needed.
• Must be authorized to work in the Netherlands.