保盛藥業股份有限公司

The Quality Assurance Specialist provides critical support to the QA Manager in ensuring GMP compliance across all external suppliers and internal laboratory operations. This role assists with tracking, monitoring, and coordinating quality activities while supporting the review and management of GMP documentation from API suppliers, excipient suppliers, CMOs, CPOs, and contract service providers. Documentation Support and Management • Assist in the review and processing of GMP documents including deviations, LIRs, change controls, and complaints • Track document review timelines and ensure timely completion of quality assessments • Maintain organized filing systems and document control databases • Prepare preliminary document reviews and summaries for QA Manager approval Supplier and Contract Service Provider Monitoring • Monitor compliance status and performance metrics for API suppliers, excipient suppliers, CMOs, CPOs, and contract service providers • Track supplier audit schedules, findings, and corrective action completion • Maintain supplier qualification status records and renewal schedules • Assist with supplier communication and coordination of quality-related activities Laboratory Quality Support • Assist with tracking and monitoring of laboratory analytical results and trending • Support method validation activities by organizing protocols, data, and reports • Monitor instrument qualification schedules and maintenance activities • Track laboratory investigation timelines and CAPA implementation Quality System Administration • Maintain quality management system databases and tracking tools • Generate routine quality reports and performance metrics • Support CAPA tracking and implementation monitoring Project Coordination and Communication • Coordinate meetings, follow-up activities, and action item tracking • Assist with cross-functional project support and quality deliverables

1. 每月營運資料彙整與分析及管理報表編制(美國關係企業) 2. 董事會、工商登記、員工認股權及通報重大訊息予母公司(保瑞)等股務相關作業 3. 支援財會部門作業(如收付款作業、月結及預算編製) 4. EGS窗口與母公司對接 5. 各項專案規劃及推動執行 6. 不定時編製或提供主管所需報表或文件 7. 其他主管交代之事項