Validation Process Analyst

Description

Job Summary: A professional responsible for planning, executing, and monitoring validation and qualification processes to ensure robustness and regulatory compliance. Key Highlights: 1. Lead and execute process and system validations. 2. Develop and review the Master Validation Plan. 3. Work in an environment focused on continuous improvement and risk mitigation. **JOB MISSION:** Plan, execute, and monitor validation and qualification processes to ensure robustness, reproducibility, and regulatory compliance, promoting continuous improvement and operational risk mitigation. **RESPONSIBILITIES:** * Prepare, review, and approve qualification protocols and reports; * Review and approve third-party qualification protocols and reports; * Lead and/or execute validations; * Develop and review validation-related procedures, identifying and making them available in electronic and physical formats as required; * Develop and review the Master Validation Plan; * Manage documentation for validation processes; * Support internal and external audit processes by providing required documentation; * Support procedure review processes and report identified nonconformities to Leadership; * Support and execute planning and delivery of training related to procedure and validation work instruction revisions, ensuring all new documentation complies with Quality Management System (QMS) standards. **RESPONSIBILITIES:** * Complete all forms required by the Quality Management System (QMS), ensuring the effectiveness and efficiency of company processes. * Identify nonconforming situations to inform immediate Leadership of potential deviations, preventing adverse impact on the Quality Management System (QMS). * Ensure proper maintenance and safety of equipment and work resources, while observing safety, maintenance, organization, and cleanliness standards at the workplace. * Participate in internal or external training and capacity-building programs, fully or partially subsidized by the Company, to contribute to personal development. * Perform tasks whenever requested for urgent activities, collaborating within the scope of technical competence to meet deadlines and achieve intended results. * Comply with all applicable procedures, such as gowning requirements, access restrictions to production areas, and Company policies and standards, ensuring adherence to established quality, health, and safety regulations. * Properly use PPE (Personal Protective Equipment) to ensure personal protection in the workplace, prevent accidents, and preserve physical integrity. * Perform other related tasks as assigned by Leadership. **REQUIREMENTS:** Bachelor’s degree completed in one of the following fields: quality management, pharmacy, chemistry, biomedical science, chemical engineering, or related disciplines. Basic English Employment Type: Full-time CLT Salary: R$3\.594,98 per month Benefits: * Medical assistance * Dental assistance * Fuel allowance * Daycare allowance * Free parking * Meal voucher * Food allowance * Transportation allowance Work Location: On-site