1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines.
2. Support day-to-day Quality Assurance – Operations.
3. Perform batch disposition activities within specified timelines.
4. Ensure timely review of batch records, SOPs, investigations, and adherence to quality agreements.
5. Set meaningful goals, metrics for groups, and manage performance.
6. Ensure safe, quality, and timely work.
7. Participate in continuous improvement projects, including QA systems and shopfloor processes.
8. Manage non-conformances investigation and compliance.
9. Ensure quality production and operation in accordance with schedule.
10. Quality Assurance management, covering documentation control, batch record review, investigations, production support, training, and compliance initiatives.

全職
品質管理, 學名藥開發
待遇面議
南投製程品質保證(資深)專員
OQ (Sr.)Specialist
- 發布日期:
- 需求人數:5-8人
- 上班時段:日班/大夜班,8:00-20:00,需輪班
- 上班地點: 南投縣南投市成功一路30號 (南崗工業區)
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職務介紹
職務條件
學歷要求
大學、碩士
科系要求
化學工程相關、自然科學學科類、醫藥衛生學科類
語文能力
英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
工作經歷
1年以上
工作技能
Possessing the following qualifications is considered advantageous:
1. Familiar PIC/S GMP
2. Experience with US/EU/TFDA inspections
公司簡介
