美時化學製藥股份有限公司
(資深) 品保專員 (Sr.) QA Specialist, AP
10/9 Updated
Array
English Required
Full-time
Mid to Senior Level
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
南投縣南投市
Required
Language Requirements
English
聽/中等、說/中等、讀/中等、寫/中等
Work Experience
2年以上
Job Description
1. Facilitate the Lotus disposition process including:
-Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis.
-Managing timelines and resources to ensure the disposition of material in accordance with Lotus' SOPs and within agreed timelines.
2. Support and ensures the successful day-to-day operations for the company.
3. Perform batch disposition activities in accordance with Lotus' SOPs and within agreed timelines.
4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements.
5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner.
6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor function.
7. Managing and/or participating in the investigation of non-conformances, e.g. product complaints, deviations, and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations.
8. Provide Quality oversight on the shopfloor GxP activities with routine GEMBA.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
化學相關、藥學相關、食品科學相關
Work Schedule
08:00~17:00
Leave Policy
週休二日
Job Category
Quality Control / Inspection Staff
QA / QC Engineer
QA / QC Supervisor
南投縣南投市
藥品製造業
美時化學製藥成立於 1966 年，是一個立足台灣、放眼國際的學名藥廠，目前為台灣營收規模最大的製藥公司，專注生產口服癌症用藥並銷售全世界。
美時以亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PMDA、中國 FDA 及巴西 ANVISA 認證的藥廠，全力以高品質、高近用性的藥物滿足未竟的醫藥需求，改善人類生活品質，致力為病患、員工與所有利害關係人創造最大利益。
透過目前足跡廣布台灣、韓國、泰國、越南、新加坡、香港、馬來西亞、菲律賓、與中國的直營市場，以及與一線藥廠成為合作夥伴，美時的高價值產品得以銷售至世界各角落，是少數能進軍所有國際市場的台灣藥廠。
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