汐止總公司-品質管理處/汐止品保部-經理

1. Lead and mentor QA team members, ensuring compliance with internal SOPs, GMP regulations, and company quality policies.
2. Oversee daily QA operations including batch record review, deviation handling, change control review, and product release activities.
3. Ensure quality systems and manufacturing activities comply with cGMP standards and applicable regulatory requirements (FDA, EMA, TFDA, PMDA as applicable).
4. Support preparation for internal audits, client audits, and regulatory inspections, and participate in audit responses and CAPA implementation.
5. Manage quality documentation and records, including batch records, deviations,
investigations, CAPA, and change control documentation.
6. Ensure timely and accurate completion of QA documentation and maintain data integrity in accordance with ALCOA+ principles.
7. Identify opportunities for continuous improvement within QA operations and support implementation of quality system improvements.
8.Implement and monitor corrective and preventive actions (CAPA) to ensure effective resolution of quality events.
9. Oversee QA support for technology transfer, process validation, and GMP
manufacturing activities to ensure compliance with regulatory and client requirements.