Validation Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7chtxw

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, /b ensuring 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 the leader 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 other applicable 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 quality management 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 assigned /li /ul pworking closely with the involved teams. /p 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 h3In This Role, You Are Encouraged To /h3 ul liTake ownership of outcomes, not just tasks /li liBring ideas forward and turn them into solutions /li liCollaborate openly and contribute to shared success /li /ul h3Skills Experience /h3 ul liScientific Master’s Degree /li li+2 years’ experience in Validation in a multinational company (preferably in a pharmaceutical and medical devices company) /li liKnowledge of the internal audit: process, features techniques /li liKnowledge of applicable regulatory, standards, global manufacturing practices; /li liLegal and standard requirements linked to the relevant applicable standard /li liIT Tool /li liGood English language proficiency /li /ul h3Mindset Ways of Working /h3 h3We Are Looking For People Who /h3 ul liAre curious,



hands‑on problem solvers /li liThrive in fast‑paced and dynamic environments /li liTake ownership and accountability /li liValue collaboration over silos /li liAre motivated by purpose and real‑world impact /li /ul h3How We Work /h3 pOur culture is shaped by the values that guide our everyday decisions and interactions: /p ul liTrust Respect Everyone – We value diverse perspectives and foster an environment where people feel heard and respected. /li liListen Humbly, Communicate Transparently – We approach conversations with curiosity, openness, and clarity. /li liBe Accountable – We take ownership of our actions, commitments, and outcomes. /li liBe Ethical, always – We act with integrity and uphold the highest standards wherever we work. /li liDeliver Results – We set ambitious goals and pursue them with consistency, discipline, and determination. /li /ul h3What We Offer /h3 pAt Stevanato Group, we believe that great performance is sustained over time through the right combination of tools, support, wellbeing, and continuous development. As part of our Total Rewards offering in Italy, you will vantaggi from: /p ul liComprehensive health and protection coverage, /li liCanteen services, supporting your everyday experience at work /li liAccess to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices /li liOpportunities to participate in wellbeing, social, and engagement initiatives /li liContinuous learning opportunities, including on-demand language training across a wide range of languages /li /ul pSalary starting from: €35.000 /p pThe actual compensation will depend on a variety of job‑related factors, including geographic location, professional experience, education, and skill level. /p h3Our Commitment /h3 pAt Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that potential, mindset, and motivation matter just as much as experience. /p h3Our Selection Journey /h3 pOur selection process is designed as a two‑way conversation. Through a mix of interviews and, where relevant, practical exercises, we aim to understand your experience and how you approach challenges while giving you a clear view of our culture, expectations, and growth opportunities. /p h3About Us /h3 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7chtxw