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 Do
VALIDATION 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 statis
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