Validation and Compliance Specialist
1 month ago
At DiaSorin, we're committed to delivering innovative healthcare solutions that make a meaningful difference in the world. As a Validation and Compliance Specialist, you'll play a critical role in ensuring our products and processes meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Lead and coordinate the Site Validation Review Board, overseeing the implementation of the S-VMP.
- Develop, execute, and maintain validation protocols and reports for all manufacturing processes in accordance with ISO 13485 and IVDR regulations.
- Validate and verify analytical and testing methods to ensure they are suitable for their intended use, producing reliable and reproducible results.
- Conduct validation of spreadsheets used for data handling and analysis to ensure accuracy and compliance with regulatory standards.
- Contribute to project Cross Functional Teams (CFTs) as a Validation subject matter expert, ensuring adherence to validation policies, procedures, safety, and training.
Requirements:
- Strong background in validation processes, quality systems, risk management, and regulatory compliance within the medical device or IVD sector.
- IVDD/IVDR compliance knowledge advantageous.
- Familiarity with risk management principles and practices in a regulated environment.
- Managing timelines and prioritizing workload to meet business needs.
About DiaSorin:
DiaSorin is a global leader in the diagnostic industry, committed to delivering innovative healthcare solutions that make a meaningful difference in the world. We're passionate about innovation, diversity, and making a positive impact on healthcare. If you're looking for a challenging and rewarding career, join our team and be part of our mission to improve patient care and outcomes.
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