Quality Coordinator - R&D

Description

Job Summary: Responsible for ensuring implementation of the Quality Management System within the R&D Latam department and compliance with Ceva standards. Key Highlights: 1. Ensure implementation of the Quality Management System in R&D Latam. 2. Audit and ensure compliance of quality systems and procedures. 3. Release investigational products and audit clinical research centers. **Quality Coordinator \- R\&D** A company’s success depends on the passionate people who work there. Together, we share our talents. As one of the leading animal health companies, Ceva Animal Health believes its success is linked to its passionate people who research, develop, produce, and deliver innovative health solutions for all animals—contributing to the future of our diverse planet. We are committed to ensuring the highest possible level of care and welfare for livestock (poultry, swine, ruminants), companion animals (dogs and cats), and wildlife. Our vision “Together, Beyond Animal Health” emphasizes that human health, animal health, and planetary health are fully interconnected. More than ever, Ceva is committed to a “One Health” approach. As part of our “Diversity, Inclusion and Equity” policy, Ceva Animal Health is committed to employing people with disabilities and will make necessary accommodations during the selection process to ensure inclusion and accessibility for all candidates. To request an accommodation, please contact a member of Ceva’s Human Resources team. **Your Responsibilities:** * Responsible for ensuring implementation of the Quality Management System within the R\&D – Latam department aligned with global processes; * Establish, together with Bio \& Pharma Development, quality systems across departments, laboratories, and partners in compliance with Ceva standards; * Implement internal control processes and information reliability; * Execute internal audit programs aligned with corporate requirements across quality-related systems and procedures, aiming to identify improvement opportunities in processes, systems, and tasks; * Implement and organize the work of R\&D Quality Assurance for BR and AR campuses (Santa Fé, Paulínia, Juatuba, and Campinas); * Comply with the Global Quality Assurance standard defined for vaccine and pharmaceutical development and registration; * Ensure compliance of laboratory equipment and systems used by R\&D; * Audit different phases of clinical studies in accordance with Good Clinical Practice guidelines and internal procedures; * Release investigational products for clinical study execution; * Audit Clinical Research Centers to ensure compliance with internal procedures and guidelines. **Your Profile:** * Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or Veterinary Medicine. * Advanced/Fluent English; Intermediate Spanish minimum. * Knowledge and expertise in Quality Management Systems and new product development and laboratories; * Experience with process validation, Good Manufacturing Practices, and Good Clinical Practices; * Understanding of research and development stages for new biological and pharmaceutical products; * Familiarity with MAPA regulations and other key guidelines (VICH, EMA, ANVISA). * Experience conducting internal and external audits