Computerized System Validation (CSV) Professional Analyst

Description

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 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, making Radix increasingly consolidated as a **global** company. Do you want to be part of this story and turn ideas and dreams into reality? #### **As a Computerized System Validation (CSV) Analyst, you will:** * Develop, review, and execute validation deliverables for computerized systems, including Validation Plan (VP), Risk Assessment (RA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), and Validation Summary Report (VSR). * Perform risk-based validation activities, following the principles of GAMP 5\. * Ensure system compliance with applicable regulatory requirements and quality standards. * Collaborate with Quality Assurance (QA), Information Technology (IT), Engineering, Manufacturing, Laboratory, and business areas. * Participate in deviation investigations, implementation of corrective and preventive actions (CAPA), and change control activities. * Maintain all validation lifecycle documentation in compliance with company procedures, client requirements, and regulatory expectations. #### **For this position, you must have:** * A degree in Engineering, Information Technology, Computer Science, Pharmacy, Biotechnology, Life Sciences, or related fields. We also consider professionals with other backgrounds, prioritizing practical experience. * Experience in Computerized System Validation (CSV) in regulated industries, such as Pharmaceutical, Biotechnology, Medical Devices, or Life Sciences. * Solid knowledge of software and computerized system validation methodologies. * Experience with validation lifecycle management and computerized system compliance. * Excellent ability to prepare technical documentation and write validation documents. * Strong analytical and problem-solving skills. * Ability to work independently, managing multiple projects simultaneously. * Advanced/Fluent English, with the ability to conduct meetings, prepare technical documentation, and interact fully in English with clients, teams, and international stakeholders. #### **It is a plus if you have:** * Solid knowledge of regulations and guidelines from agencies such as **FDA**, **EMA**, and **ANVISA**. * Experience 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 * Consultant doctor 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 for mental health support, psychiatrist, and consultant doctor available. **Did you like it?** **\#VemPraRadix** **Job Code:** 6c96