As a QA Validation Specialist at Medable for almost two years, I have been applying my expertise in Computer System Validation (CSV), Quality Assurance (QA), and Data Integrity to support the development and delivery of innovative and compliant solutions for the pharmaceutical industry. I have a solid understanding of FDA Validation Guidelines on GXP regulated environment, and I can effectively present information and respond to the questions from managers, team, and co-workers.My core competencies include conducting Impact Analysis, Risk Analysis, and System Compliance Assessment, as well as implementing Corrective Action Preventive Actions (CAPA) and periodic reviews. I have also participated in cross-functional activities using these skills to ensure alignment with ISO 13485, 21 CFR Part 11, 820, 210, and EU Annex 11 standards and guidelines. I am passionate about maintaining high quality and data integrity standards, and I strive to continuously improve my knowledge and skills in this field.