【醫療 HEC】品質部 - 品質合規(資深)專員 (Senior) Specialist, Quality Compliance

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