『保瑞-桃園廠』QA Inspector 品保/製程稽查員

1. Incoming Material Management 進料管理
Review incoming materials related documents, perform material sampling, purified water sampling, ID testing and complete material release activities.
審查進料相關文件，執行物料取樣、純化水取樣、鑑別試驗（ID Testing），並完成物料放行作業。
2. Packaging Artwork Management 包裝圖稿管理
Printing Packaging Material Artwork Management.
負責印刷包裝材料圖稿（Artwork）管理。
3. Batch Record Review 批次紀錄審查
Review batch records and related documents to confirm the information is complete, accurate, and valid for batch disposition.
審查批次紀錄及相關文件，確認資訊完整、正確且有效，作為批次處置與放行的依據。
4. Stability Program Management 安定性試驗管理
Responsible for stability program management, stability chamber management and reviewing RMS report of stability chambers/room.
負責安定性試驗計畫及安定性試驗箱／室管理，並審查相關 RMS 報告。
5. Sample Management 樣品管理
Responsible for reserve/reference/retention sample management and conduct the annual inspection program.
負責備用樣品、對照品及留樣（Reserve / Reference / Retention Samples）管理，並執行年度檢查計畫。
6. Change Control Management 變更管制管理
Ensure change control system is robust and routed in a timely manner.
確保變更管制系統完善運作，並於規定時程內完成相關流程及簽核。
7. GDP Compliance 優良運銷規範管理
Ensure Bora GDP procedures are established, followed and executed appropriately in compliance with Current Good Distribution Practices (cGDPs).
確保保瑞 GDP 作業程序完善建立、遵循並適當執行，以符合現行優良運銷規範（cGDPs）。
8. Deviation, Investigation and CAPA Management 偏差調查及矯正預防措施管理
Participate, facilitate and review investigations of deviation, laboratory investigations and product complaint. Propose, review and implement corrective and preventive actions to address the identified root cause(s). Review and approve the outcome of effective checks.
參與、協調及審查偏差事件、實驗室調查及產品客訴調查。針對確認的根本原因提出、審查並執行矯正與預防措施（CAPA），並審查及核准改善措施有效性確認結果。
9. Annual Product Review 年度產品品質回顧
Collect, compile, review annual product review document. Collect documents for customer annual report request(s).
蒐集、彙整及審查年度產品品質回顧（APR）文件，並蒐集客戶年度報告所需資料。
10. QCAL Statistical Support QCAL 統計支援
Develop, maintain and provide statistics support and consult of QCAL.
建立及維護 QCAL 相關統計資料，並提供統計分析支援與諮詢。
11. Quality Risk Management 品質風險管理
Handle and/or coordinate quality risk management of the site for risks evaluations, controls and mitigations.
處理及／或協調廠區品質風險管理，包括風險評估、風險控制及風險降低措施。
12. Other Assigned Duties 其他交辦事項
Other tasks as assigned by the company.
執行公司交辦的其他事項。

※ 薪資依應徵者學經歷條件不同調整核定。