『竹南科學園區』QA Associate

Ensure the change control system is robust and processed in a timely manner. Plan, execute, and follow up on the internal audit program to ensure conformance with current Good Manufacturing Practices (cGMPs). Coordinate, accompany, and follow up on GMP inspections, PAIs for new products, and third-party audits conducted by customers or regulatory authorities. Perform supplier qualification and ongoing maintenance. Manage regulatory updates, implementation, and compliance-related procedures. Participate in, facilitate, and review investigations of deviations, laboratory incidents, and product complaints. Propose, review, and implement corrective and preventive actions (CAPA) to address identified root causes. Collect, compile, and review annual product review documents. Maintain and provide statistical support for QCAL. Support cleaning validation activities. Support and execute QIPs for site innovation, improvement, and enhancement in accordance with regulatory requirements. Perform other tasks as assigned by the company.