Senior Technology and Validation Analyst

Description

Job Summary: Professional to lead and manage technology transfer projects, optimize production processes, and ensure regulatory compliance. Key Highlights: 1. Manage technology transfer projects between units and/or third parties. 2. Optimize and continuously improve production processes. 3. Plan and execute process and system validation studies. Description: * Bachelor's degree in Pharmacy, Chemistry, or Chemical Engineering; * Solid knowledge of quality standards; * Knowledge of quality tools and techniques; * Advanced Office Suite; * Intermediate English. * Lead and manage technology transfer projects between manufacturing units and/or third parties, ensuring proper transition of production processes. * Develop, review, and approve technology transfer protocols and reports aligned with regulatory requirements and Good Manufacturing Practices (GMP). * Optimize and continuously improve production processes by identifying opportunities for efficiency gains, quality improvement, and cost reduction. * Plan and execute process, cleaning, and system validation studies to ensure robustness, reproducibility, and regulatory compliance. * Develop and oversee equipment, utilities, and facility qualification protocols, ensuring compliance with national and international standards. * Participate in deviation and non-conformance investigations, proposing corrective and preventive actions (CAPA) aimed at process improvement. * Provide technical support to Production, Quality, Engineering, and R\&D departments, ensuring effective and integrated solutions. * Prepare and review technical documentation related to processes, validations, and transfers, ensuring data integrity and traceability. * Collaborate with the Regulatory Affairs department to provide technical information for submissions and renewals of registrations with competent authorities. * Coordinate technical training on new processes, validation methodologies, and continuous improvement tools. * Conduct risk analyses to mitigate failures in production and validation processes. * Interact with suppliers and external partners to ensure alignment of technical and regulatory expectations during process transfers. 2510310202231779620