ppAt Stevanato Group, what we do matters. Every solution we develop contributes to delivering life‑changing treatments to patients around the world. /p pIn this role, you will play a key part in the bQuality Validation team, /bensuring the approval and validation of all production processes and supporting functions producing a product that meets quality and regulatory requirements. /p pYou will contribute to our ambition to bsolve what matters, together /b, combining technical excellence, collaboration, and a strong sense of ownership. /p h3What You’ll Do /h3 h3VALIDATION MANAGEMENT /h3 ul liExecute 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. /li liSupport 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. /li liProvide timely and accurate all the validation documents, monitoring also third parts reports to be reviewed by theleader above for the final submission. /li liParticipate alongside the Commercial Team to carry out new projects ensuring technical assistance and validation,as well as with RD Team to define appropriate processes to guarantee the quality and reliability of the products. /li liSupport the development, optimization, transfer and validation of analytical test methods used for product, process verification activities. /li liAuthor and review analytical method validation protocols and reports in accordance with applicable GMP requirements and international guidelines. /li liDefine validation strategies and acceptance criteria for analytical methods, including assessment of accuracy, precision, specificity, linearity, range, robustness, detection limits and quantification limits.



/li liSupport analytical method transfer activities between laboratories and manufacturing sites. /li liPerform data analysis and statistical evaluation to demonstrate method suitability and maintain the validated state throughout the method lifecycle. /li /ul h3GUIDELINES AND PROCEDURES /h3 ul liContribute to cascade accurate and up-to-date information related to regulations, customer requirements, and otherapplicable standards to the team and to the other functions involved into the processes. /li liSupport the validation practices definition, ensuring inclusion within the relevant quality management system. /li liProvide technical support to other functions involved to ensure the full application of the relevant qualitymanagement system for what concerns validations process. /li liContribute to the definition and continuous improvement of analytical method validation procedures in compliance with GMP requirements and international guidance (e.g. ICH Q2(R2), ICH Q14 and applicable pharmacopoeia standards). /li /ul h3QUALITY AUDIT MANAGEMENT /h3 ul liParticipate in the audit sessions as well as during the customers technical meetings to provide accurate and timely technical services and support for the relevant topic, executes corrective and preventive actions assignedbr/working closely with the involved teams. /li /ul h3REPORTING AND MONITORING /h3 ul liElaborate appropriate reports to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues and propose to the leader above actionable initiatives to achieve appropriate and effective resolution. /li /ul pIn this role, you are encouraged to: /p ul libTake ownership of outcomes, not just tasks /b /li libBring ideas forward and turn them into solutions /b /li libCollaborate openly and contribute to shared success /b /li /ul pWe are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team! /p /p #J-18808-Ljbffr

📌 Validation Specialist (Piombino Dese)
🏢 STEVANATO GROUP
📍 Piombino Dese