Ludmila Valino Garcia

With a degree in Biological Sciences, a Master's in Immunology and an MBA in Health Innovation Management, I have over a decade's experience in the pharmaceutical sector, working for both public and private companies. My background in Quality Control and Research Development provides a solid foundation in risk analysis, change control (CM), corrective actions and preventive actions (CAPA), investigation of deviations and out-of-specification results.My skills include physicochemical and microbiological analysis at all stages of serum and vaccine production, as well as laboratory processes for the preparation and cultivation of enteropathogenic bacteria and cell culture. I develop and validate analytical and biotechnological methods, with an emphasis on techniques such as BioMol RT-PCR, qPCR and Sanger sequencing. I have experience in vaccine technology transfer and document management in accordance with regulations.I supervise the activities and schedules of the quality teams, ensuring compliance with Good Practices (BPx) and current regulations. I approve and review protocols and documents with an impact on GMP, in order to standardize and continuously improve processes and promote effective integration between areas. In the regulatory area, I work on the regularization of documents required by ANVISA and participate in internal and external audits (ANVISA, MAPA, FDA and EMA). I lead quality training, conduct process restructuring and review projects, and implement continuous improvement methodologies and quality systems. (Source: Lattes Curriculum)