12 ago - Italia
STEVANATO GROUP
At Stevanato Group, what we do matters. Every solution we develop contributes to delivering life‑changing treatments to patients around the world.
In this role, you will play a key part in the Quality Validation team, ensuring the approval and validation of all production processes and supporting functions producing a product that meets quality and regulatory requirements.
You will contribute to our ambition to solve what matters, together , combining technical excellence, collaboration, and a strong sense of ownership.
What You’ll DoValidation Management
- Execute the qualification and validation activities to achieve the validation targets according to the level of services and timing defined in the approved plan, guaranteeing compliance with applicable standards.
- Support the leader above in the definition of the qualification and validation activities, aimed at ensuring compliance with the quality management system with applicable standards and requirements.
- Provide timely and accurate all the validation documents,
monitoring also third parts reports to be reviewed by the leader above for the final submission.
- Participate alongside the Commercial Team to carry out new projects ensuring technical assistance and validation, as well as with R&D; Team to define appropriate processes to guarantee the quality and reliability of the products.
- Support the development, optimization, transfer and validation of analytical test methods used for product, process verification activities.
- Author and review analytical method validation protocols and reports in accordance with applicable GMP requirements and international guidelines.
- Define validation strategies and acceptance criteria for analytical methods, including assessment of accuracy, precision, specificity, linearity, range, robustness, detection limits and quantification limits.
- Support analytical method transfer activities between laboratories and manufacturing sites.
- Perform data analysis and statistica
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