p Specific activities and responsibilities: ulli Plan, 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. /lili Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports. /lili Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements. /lili Perform risk assessments to define validation strategies and support regulatory compliance. /lili Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems. /lili Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects. /lili Assess the impact of software implementations, upgrades, and changes on validated systems. /lili Draft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects. /lili Provide validation and compliance support during internal audits, supplier audits, and regulatory inspections. /lili Contribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations. /li /ulp Required education: /pp Bachelor's or Master's degree in Engineering,



Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field /pp Required experience : /pp4-5 years of experience /pp Required languages: /pp Italian and English /pp Required technical skills: /pulli Knowledge of GxP regulations and GMP requirements applicable to computerized systems. /lili Good understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. /lili Experience with Computerized System Validation (CSV) lifecycle and validation methodologies. /lili Understanding of software development lifecycle (SDLC) and computerized systems lifecycle management. /lili Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). /li /ulp Additional experience and/or skills: /pulli Attention to detail /lili Team working and proactivity /lili Problem solving /lili good Interpersonal skills /lili customer management /lili team management /lili availability to travel is mandatory /li /ulp Compensation range: €40000 - €45000 /pp The 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

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