汐止總公司-品質系統處/品質保證部-QA經理/資深經理

Responsible for overseeing the daily operation of Quality Assurance (QA) department, ensuring that all product and processes meet regulatory standards and internal quality requirements. This role involves supervising QA staff, managing quality documentation, supporting continuous improvement efforts, managing both client relationships and specific requirements. 1. Lead and mentor QA team members, ensuring compliance with SOPs and regulatory requirements. 2. Oversee daily QA activities, including product inspections, and release. 3. Ensure all quality processes comply with regulations and cGMP stnadards. 4. Assist in preparing for and conducting internal and external audits. 5. Manage quality records, including batch records, deviations, and CAPAs. 6. Ensure accurate and timely completion of quality documentation. 7. Identify opportunities for process improvements within the QA function. 8. Implement and monitor corrective and preventive actions. 9. Oversee quality aspects of technology transfer and process validation, ensuring that new products meet both regulatory and client requirements.