
Quality Assurance Product Labelling Specialist
1 day ago
Job Role: Quality Assurance Product Labelling Specialist
Key Responsibilities:- Review and validate lot-specific product labels to ensure accuracy and compliance
- Develop and manage Instructions for Use (IFUs) with precise technical data, maintaining consistency across all platforms
- Enter and verify data in our Technical Library (XML files), ensuring seamless integration and validation
- Process label updates through our document control system, adhering to strict regulatory standards
- Support the development of master labelling documents (labels, IFUs, packaging specs) and assist with validation activities for our auto-population system
- Upload approved documentation to internal and customer-facing platforms, guaranteeing accessibility and visibility
- A Level 5 qualification in Science, Engineering, Pharma or QA is highly desirable
- Minimum 2 years' experience in a regulated medical or diagnostics setting, with a strong understanding of quality assurance principles
- Proficiency in Microsoft Word and Excel, with knowledge of Adobe In Design and Nice Label Pro being a significant advantage
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and IVDR regulations is beneficial
As a Quality Assurance Product Labelling Specialist, you will play a crucial role in ensuring the accuracy and compliance of product labels. Your expertise in managing IFUs, entering data in our Technical Library, and processing label updates will be essential in maintaining our high standards of quality.
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