#### **About the Computerized Systems Validation (CSV) Analyst - Pharmaceutical Industry Position** **Join a living ecosystem where the future of business is created and experienced every day. Be part of this transformation!** At LUZA Group, passion, perseverance, and the drive to exceed limits define our path to success. Founded in 2006, we are a Portuguese multinational with over 1,200 talented professionals and a significant business volume. Present in strategic markets such as Portugal, Spain, Morocco, Brazil, Mexico, the United States, and China, we offer innovative solutions in engineering, IT, design, consulting, Industry 4.0, training, and recruitment. Everything we do is driven by the talent of our people. **This is a time of growth and opportunity. The future belongs to visionary minds. Join us!** **Position Objective** ----------------------- To perform computerized systems validation (Computerized System Validation - CSV) processes, ensuring compliance with regulatory standards (including Anvisa's RDCs) and good practices (GxP), contributing to ensure the quality, integrity, reliability, and traceability of systems used in pharmaceutical processes. **Main Responsibilities** -------------------------------- * Develop or review validation plans (Validation Master Plan, strategies, schedule, scope) for computerized systems. * Perform or oversee qualification activities (DQ, IQ, OQ, PQ) for critical systems. * Develop and review validation documentation: protocols, reports, traceability matrices, templates, standard operating procedures (SOPs). * Conduct risk assessments, impact assessments, and system classification. * Ensure adherence to applicable Brazilian regulations, especially Anvisa's RDCs (such as RDC 301/2019, RDC 304/2019, or other current ones), as well as international guidelines (FDA, EMA, PIC/S, GAMP). * Act as the main contact with IT teams, software vendors, operations, QA, and internal/external audits. * Support regulatory audits and inspections related to computerized systems. * Perform periodic system reviews (Periodic Review), change management (change control), and maintenance of validated state. * Participate in system implementation or upgrade projects (ERP, LIMS, MES, laboratory or manufacturing automation systems), ensuring validation requirements are met. * Monitor quality indicators, documentation, and system compliance. **Essential Requirements** ------------------------- **Education and Experience** * Bachelor’s degree in Engineering (chemical, production, software), Pharmacy, Biotechnology, Sciences, or related fields. * Proven experience in computerized systems validation (CSV) within the pharmaceutical industry or in industries requiring regulatory compliance (GMP, GxP). * Solid knowledge of RDCs applicable to the pharmaceutical sector and regulations on computerized systems (national and international standards). * Experience in developing and executing validation plans, protocols, reports, and technical document management. * Experience in qualification activities (DQ, IQ, OQ, PQ) for critical systems. * Proficiency in software and system risk analysis (e.g., FMEA, FTA, risk-based approach). * Experience with change control, maintenance of validated state, and periodic reviews. * Ability to collaborate effectively across different departments (IT, operations, QA, vendors). * Technical English proficiency (reading and understanding regulatory and technical documentation). **Desirable Competencies** * Certifications or training in CSV/regulatory quality/GAMP 5. * Experience with ERP, LIMS, MES, automation, or process control systems. * Knowledge of cloud computing, remote software validation, and validation of SaaS-based services. * Analytical mindset, attention to detail, proactivity, and strong communication skills. * Ability to manage deadlines and priorities in a regulated environment. **Location: Hybrid (Pindamonhangaba - SP)