FIE QA Manager - Pharmaceuticals Division

JOB DESCRIPTION: ABOUT ABBOTT Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. WORKING AT ABBOTT At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: • Career development with an international company where you can grow the career you dream of. • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Established Pharmaceuticals We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. MAIN PURPOSE OF ROLE: QA Manager of the local imported warehouse and assures that quality related matters associated with imported products commercially distributed in Vietnam market conform to current Good Manufacturing Practices (cGMP), Good Storage Practices (GSP), Abbott Quality standards, and other applicable regulatory standards. Position Accountability / Scope: • This individual contributor role is responsible for overseeing and performing all quality control activities associated with imported products and distribution operations to ensure product quality, safety, and regulatory compliance • Maintain quality documents to comply with Abbott Policies & Procedures and local regulations. • Full authority in controlling the overall quality operations of the warehouse. This includes budgeting and facilities. • Review and approve operating procedures to comply with Abbott policies and local regulations within the scope of the position. • Within the guidelines of QA management and GSP Compliance, has authority to recommend, evaluate and implement changes in the existing QA operation MAIN RESPONSIBILITIES 1. Quality Operations at imported product warehouse 1.1 Warehouse quality compliance • Manage daily quality operations for the FIE warehouse in compliance with applicable GSP/ GDP requirements, local regulations, and company quality standards. • Coordinate and supervise over-labeling and redressing activities to ensure compliance with approved procedures and quality requirements. • Review and maintain warehouse SOPs, batch records, and quality documentation to ensure accuracy, completeness, and data integrity. • Maintain quality records and documentation in accordance with document control requirements. 1.2 Product Release, Rejection and Investigation • Review batch documentation and related quality records to support product release and rejection decisions. • Perform quality assessment of warehouse-related events and product quality issues. • Coordinate product investigations, including product impact assessment, root cause analysis, and follow-up actions. • Escalate critical quality issues and disposition recommendations to the CDQA Manager when required. • Maintain product hold, release, and rejection records in accordance with approved procedures. 2. Quality System Management 2.1 Change Control • Initiate, assess, coordinate, and maintain Change Controls related to warehouse operations, facilities, equipment, suppliers, and processes. • Track implementation of approved changes and verify completion of required