醫療 HEC】品質部

5 days ago

Taoyuan City Taoyuan City, Taiwan DKSH Full time NT$360,000 - NT$720,000 per year

Job Summary
Dealing with work related to quality and compliance.

*General Responsibilities*

  • Responsible for the follow-up on the corrective and preventive action of

deviation report, CAPA form, complaint, internal audit.

  • Assist in the maintenance of the Risk Management and files regarding

Quality Deviation/Change Control.

  • Responsible for regional KPI reporting.
  • Perform calibration activities, such as perform calibration/ validation and

raise report.

  • Perform temperature mapping activities
  • Oversees warehouse temperature profile, van temperature record, pest

control, facility maintenance monitoring.

  • Responsible for preparing validation protocol and summary report.
  • Assignment will be subject to management decision based on

department needs.

作業地點有兩個倉庫 (1)高上倉:楊梅區高上路一段150號 (2)龍潭倉:楊梅區梅獅路二段629號

上班時段
日班、09:00-18:00

Functional Skills And Knowledge
工作技能
規劃並執行品質管理系統

日常檢查及異常狀況初步研判

測量儀器之檢驗與校正

測量儀器之檢驗與校正

客訴處理及控管

零件供應商評鑑考核

其他條件

  • Quality assurance or quality control for 1~3 years at least 至少1~3年以上品保或品管的工作經驗
  • GMP or ISO related experience 有GMP或ISO相關工作經驗(must have)
  • Experience in Change Control / Complaint Handling / Deviation Investigation / Equipment Calibration and Validation變更管制/客訴處理/異常調查/設備校正與確效工作經驗(至少具備其中一樣)
  • Good communication skills. 良好的溝通能力
  • Good problem-solving skill and logical thinking 具有良好的解決問題以及邏輯思考能力
  • Proactive mindset and behavior 積極主動、樂於協助同仁
  • Independent contributor and a team player能獨立完成工作,並具有團隊合作精神
  • Accountable and responsible當責盡職有責任心

語文條件
英文(聽:中等、說:中等、讀:中等、寫:中等)

擅長工具
Excel

PowerPoint

Word

Education
大學以上

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