Partnership for Supply Chain Management System (PFSCM)
TITLE: Product Quality Assurance Officer
REPORTS TO: Product Quality Assurance Manager
LOCATION: Project Management Office, Woerden, Netherlands (PMO-NL)
The Partnership for Supply Chain Management (PFSCM) brings together multiple private sector and non-governmental organizations that are among the most trusted names in supply chain management and international public health and development in the world. PFSCM has been recognized internationally for its work to save lives through stronger public health supply chains; the partnership won two supply chain distinction awards from the European Supply Chain and Logistics Summit in 2010 and was a finalist in the 2012 Supply Chain Innovation Award Competition sponsored by the Council of Supply Chain Management Professionals (CSCMP) and SupplyChainBrain.
The Global Fund to Fight AIDS, Tuberculosis and Malaria is a major financing institution in the fight against these diseases in 140 countries. The Global Fund selected PFSCM to be one of the Procurement Service Agents for Global Fund principal recipients, under its Pooled Procurement Mechanism aimed at ensuring a cost-effective and efficient procurement process that meets all the Global Fund standards for a Procurement Service Agent. This service provides support to countries to resolve procurement bottlenecks and supply chain management challenges and to facilitate timely access to pharmaceuticals and other health products.
In addition, PFSCM implements other supply chain management projects with other client/donors including several developing country governments.
The Product Quality Assurance (QA) Officer is responsible to ensure quality compliance in all PFSCM projects, working with the Product Quality Assurance Manager. The Officer is expected to ensure that all product and manufacturer-related documentation align with the quality requirements set forth in the relevant policies. The Officer is expected to support the product dossier review process in order to ensure completeness and accuracy. The Product QA Officer is additionally responsible to manage the QA knowledge management repository to ensure that product quality-related information is accurate and accessible.
The Product QA Officer is also expected to support the Product QA Manager and work closely with multiple Units across PFSCM and members of the Product QA Unit.
- Manage and maintain product dossiers or technical documentation submitted as part of the PFSCM’s product prequalification process.
- 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 Product QA Manager.
- Ensure proper filing, access, and retrieval of product dossiers and records related to QA decisions.
- Coordinate with the Product QA Data Coordinator to ensure that only approved products are maintained in the PFSCM item master in the ERP system.
- Maintain the approved vendor list to ensure the profile and certificates/licenses of approved vendors are current and up-to-date (both within the ERP system and in PFSCM document management system).
- Support the Product QA Manager to undertake screening of potential wholesalers and assist in audit preparation/planning when required.
- Assist the Product QA Manager in coordinating QC sampling and testing activities by following up with operational units on shipping documents, completing relevant forms for sampling request, and timely processing of invoices.
- Establish and maintain a knowledge management repository for product quality-related norms and standards for different product categories; track its changes and revisions to inform impact assessment; and monitor alerts and notice of concerns/warning letters issued by WHO, regulatory bodies, and manufacturers so that necessary actions and response mechanisms may be identified in timely manner.
- Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions in line with PFSCM’s Quality Management System.
- Bachelor’s degree in Healthcare and Life Sciences or other relevant field or equivalent experience.
- 3+ years’ work experience in quality assurance/regulatory affairs in a medical device industry, healthcare organization.
- Knowledge about Good Manufacturing Practices, Good Distribution Practices, ISO 13485, and other relevant standards.
- Understanding of the international regulatory environment and medical device regulations.
Knowledge of the international pharmaceutical and health products market with specific reference to the essential commodities required for HIV/AIDS, Tuberculosis, and Malaria.
Experience in the international, public health sector is preferred.
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.