The first thing you need to know is that you will not fall into a routine here. Radix develops solutions for companies in different sectors and industries. Each project has its own technologies, solutions, and deadlines, and you will have the opportunity to work on and experience different challenges. In addition to our operations in Brazil, with offices in Rio de Janeiro, São Paulo, and Belo Horizonte, we also have branches in the United States, which is helping Radix consolidate itself as a **global** company. Do you want to be part of this story and turn ideas and dreams into reality? As a **Junior Computerized System Validation (CSV) Analyst**, you will: * Support the development, review, and execution of validation deliverables for computerized systems, including the Validation Plan (VP), Risk Assessment (RA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), and Validation Summary Report (VSR). * Perform validation tests under the guidance of senior team members. * Assist in maintaining validation lifecycle documentation, ensuring compliance with company, client, and regulatory requirements. * Support risk-based validation activities, following GAMP 5 principles. * Work in conjunction with Quality Assurance (QA), Information Technology (IT), Engineering, Manufacturing, Laboratory, and business areas. * Participate in deviation investigations, Change Control activities, and the implementation of Corrective and Preventive Actions (CAPA), when applicable. * Ensure that all documentation is complete, accurate, and in compliance with established procedures. * Continuously develop technical and regulatory knowledge related to Computerized System Validation (CSV) and GxP systems. #### **For this position, you must have:** * A degree in Engineering, Information Technology, Computer Science, Pharmacy, Biotechnology, Life Sciences, or related fields. Equivalent professional experience may also be considered. * Basic knowledge of the software lifecycle and computerized systems. * Good analytical and problem-solving skills. * Attention to detail and good organization. * Good verbal and written communication skills. * Interest in learning and working collaboratively in multidisciplinary teams. * Advanced/Fluent English, with the ability to participate in meetings, prepare technical documentation, and communicate effectively with clients and international teams. #### **It is a plus if you have:** * Previous experience in Computerized System Validation (CSV), Quality Assurance (QA), Information Technology (IT), or Engineering. * Experience in regulated industries, such as Pharmaceutical, Biotechnology, Medical Devices, or Life Sciences. * Basic knowledge of computerized system validation and GxP concepts. * Knowledge of regulations and guidelines from agencies such as the **FDA**, **EMA**, and **ANVISA**. * Familiarity with international standards and good practices, such as **PIC/S GMP** and **ISPE GAMP 5**. * Knowledge of Data Integrity principles **ALCOA+**. * Knowledge of a second language, in addition to English. **Benefits:** * National Medical Assistance (for the holder and dependents, with private room) * National Dental Assistance (for the holder and dependents) * Flexible meal/food voucher * Home office allowance * Day off (in the month of your birthday) * Wellhub (formerly Gympass) * Extended Maternity Leave (6 months) and Paternity Leave (20 days) * Childcare allowance for children up to 3 years old (per child) * Mental health support with Wellz * Benefits Club with discounts from various partners * Agreement with educational institutions and language courses * Professional Development (Corporate University) * Partnership with a coworking company in Brazil * Quality of Life and Well-Being Program * Consulting physician for monitoring radixers * Incentive plans **Radix is always at the top of the Best Companies to Work For because:** * We have committed, dedicated, curious, and innovative professionals. * Team spirit is our greatest strength. We work cooperatively and know that we are together, rowing in the same direction. * We have a diverse environment that values equity and inclusion. * Our working hours are flexible, and in almost all projects, it is possible to work from anywhere in Brazil. * We value well-being and care for our people, with programs supporting mental health, psychiatry, and a consulting physician available. **Did you like it?** **#VemPraRadix** **Job Code:** 2677
João Silva
Indeed · HR
João Silva
Indeed · HR
