Qm Officer - Quality Management Officer

Mô tả công việc:

Product quality management

• Check COAs and product label artworks prior to importation, ensuring all information complies with legal regulations and approved product dossiers.
• Inspect product quality upon warehousing, customer returns, or when incidents arise during operations. Coordinate with relevant departments or manufacturers to resolve any arising issues.
• Manage secondary labeling activities, including managing and updating secondary label information based on approved templates, ordering label printing, supervising and coordinating labeling activities, and reviewing secondary labeling batch records.
• Monitor product quality trends and report any abnormalities to management.
• Monitor shipment temperature data during transportation.
• Inspect and supervise product destruction.
• Prepare periodic reports for special controlled drugs.

Quality management system

• Draft, review, and revise SOPs in accordance with current regulations. Monitor SOP compliance across relevant departments. Control, issue, and archive assigned documents and records.
• Perform temperature mapping for warehouses (ambient and cold storage), transport vehicles, and cold storage boxes. Monitor the data logger calibration schedule.
• Prepare documentation for and host external audits/inspections (GSP, GDP, customer audits, ETC.) within assigned responsibilities. Support the implementation of CAPA plans.
• Prepare periodic reports on the quality management system.
• Support the coordination and supervision of Change Control implementation.
• Support the evaluation and quality monitoring of suppliers.
• Perform other tasks as required.