QA Engineer validating document automation applications for PwC document automation team in Prague. Key role in quality assurance and coordination with cross - functional teams to enhance output.
TM
Hybrid Quality Assurance & Regulatory Officer – Non Pharmacist Degree
Posted last week
About the role
- Quality Assurance & Regulatory Officer ensuring compliance in the procurement of pharmaceuticals and medical devices for PFSCM in Netherlands. Involves liaising with clients and managing product documentation.
Responsibilities
- Ensure quality and regulatory compliance in the procurement of pharmaceuticals, in-vitro diagnostics, and medical devices
- Support the evaluation and review of product-related matters
- Liaise with client QA units, service providers, or manufacturers
- Ensure alignment between the Global Fund’s lists of eligible products and PFSCM’s item master
- Provide support to the QA&R Manager and QA&R staff
- Work closely with multiple units across PFSCM
- Participate in the product dossier review process
- Manage and maintain product dossiers and technical documentation
- Assist with product inspection, sampling, and QC testing
- Support investigation of product quality-related incidents
Requirements
- Bachelor’s degree in Healthcare and Life Sciences or other relevant field
- 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
- Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint
- Advanced user level of Excel preferred.
- Must be authorized to work in the Netherlands.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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