醫療 HEC】品質部

1 day ago

Taiwan TYNOP DKSH Spain Full time NT$400,000 - NT$600,000 per year

Job Summary

Dealing with work related to quality and compliance.

General Responsibilities

1. Responsible for the follow-up on the corrective and preventive action of
deviation report, CAPA form, complaint, internal audit.
2. Assist in the maintenance of the Risk Management and files regarding
Quality Deviation/Change Control.
3. Responsible for regional KPI reporting.
4. Perform calibration activities, such as perform calibration/ validation and
raise report.
5. Perform temperature mapping activities
6. Oversees warehouse temperature profile, van temperature record, pest
control, facility maintenance monitoring.
7. Responsible for preparing validation protocol and summary report.
8. 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

1. 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
2. GMP or ISO related experience 有GMP或ISO相關工作經驗(must have)
3.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)
4. Good communication skills. 良好的溝通能力
5. Good problem-solving skill and logical thinking 具有良好的解決問題以及邏輯思考能力
6. Proactive mindset and behavior 積極主動、樂於協助同仁
7. Independent contributor and a team player能獨立完成工作,並具有團隊合作精神
8. 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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