Experienced Quality Assurance professional with 13 years and 6 months of experience. Core competencies include audit and compliance, quality management systems, new product approval and launches, technology transfer, regulatory notifications, pharmacopoeial implementations, quality technical agreements, and in-process quality assurance. Proficient in various quality assurance activities such as deviation management, change control, product failure investigations, complaint handling, corrective and preventive actions, and risk assessment. Strong collaboration with internal stakeholders and involvement in strategic projects.