About the role

Quality Assurance & Regulatory Officer managing the procurement compliance of health products for low- and middle-income countries. Supporting quality assurance processes and maintaining product documentation.

Responsibilities

Ensure that processes/operations do not compromise the quality of medicines and health products procured and supplied by PFSCM and comply with the client’s QA policies
Provide inputs on PFSCM’s product prequalification process and manage and maintain product dossiers or technical documentation submitted as part of PFSCM’s product prequalification program
Compile and complete the initial screening of product dossiers regarding pharmaceutical, medical, in-vitro diagnostic devices, and food intended to be used for medical purposes
Keep the product dossiers up to date with the latest/new technical documentation/certificates
Ensure proper filing, access, and retrieval of product dossiers and records related to QA decisions during the product management lifecycle
Ensure completeness and accuracy of product dossiers received from suppliers
Collaborate with the Sourcing & Supplier Contracts unit to manage information in the PFSCM SRM tool by ensuring QA compliance
Support investigation of product quality-related incidents and complaints to facilitate root cause analysis and implementation of appropriate corrective and preventive actions
Gather information, providing input for investigation and contributing to the resolution to support QA-related incidents.

Pharmacy Degree required
Bachelor’s degree in Healthcare and Life Sciences or other relevant field is a plus
5+ years’ work experience in quality assurance/regulatory affairs in the medical device & diagnostics industry, pharmaceutical, or healthcare organization
Certified EU Good Distribution Practices is a plus
Knowledge about Good Manufacturing Practices, Good Storage and Distribution Practices, ISO 13485, and other relevant standards
Understanding of the pharmaceutical and medical device & diagnostics regulatory environment, both at the international and country level
Knowledge of the international health products market with specific reference to essential diagnostics required for HIV/AIDS, tuberculosis, and malaria
Experience with compiling and reviewing pharmaceutical and non-pharmaceutical product dossiers
Understanding of quality data and stability profiles of pharmaceutical products and medical device & diagnostic, especially for temperature-sensitive products
Experience working with developing countries is a plus
Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint
Advanced user level of Excel preferred
Willingness and availability to travel, and perform other duties as needed
Must be authorized to work in the Netherlands.