Quality Assurance Associate at Prollenium focuses on compliance and documentation for medical devices. Responsible for audits, QMS training, and supplier evaluation in a hybrid work environment.
TM
Hybrid Quality Assurance & Regulatory Officer
Posted 4 hours ago
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.
Requirements
- 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.
Benefits
- Health insurance
- Professional development
- Flexible working arrangements
Job title
Job type
Experience level
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Not specified
Degree requirement
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