ph3Specific activities and responsibilities /h3 ul liPlan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements. /li liPrepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports. /li liSupport clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements. /li liPerform risk assessments to define validation strategies and support regulatory compliance. /li liSupport Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems. /li liCollaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects. /li liAssess the impact of software implementations, upgrades, and changes on validated systems. /li liDraft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects. /li liProvide validation and compliance support during internal audits, supplier audits, and regulatory inspections. /li liContribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations.



/li /ul h3Required education /h3 pBachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field /p h3Required experience /h3 p4-5 years of experience /p h3Required languages /h3 pItalian and English /p h3Required technical skills /h3 ul liKnowledge of GxP regulations and GMP requirements applicable to computerized systems. /li liGood understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. /li liExperience with Computerized System Validation (CSV) lifecycle and validation methodologies. /li liUnderstanding of software development lifecycle (SDLC) and computerized systems lifecycle management. /li liProficiency in Microsoft Office Suite (Word, Excel, PowerPoint). /li /ul h3Additional experience and/or skills /h3 ul liTeam working and proactivity /li liProblem solving /li ligood Interpersonal skills /li liteam management /li liavailability to travel is mandatory /li /ul pThe compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements. /p /p #J-18808-Ljbffr

📌 Validation Specialist (CSV - Data & Compliance) (Roma)
🏢 Productlife Group
📍 Roma