求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Quality Assurance Specialist

  • 全職

Objectives and Scope of Position:
Quality Assurance Specialist is responsible for carrying out tasks and projects related to manage QA activities within Roche Taiwan as required by GMP and Roche standards. Supports to assure full local GMP compliance; handling quality issues, conducting auditing, providing quality related advice to company personnel and ensuring Roche Taiwan, contracted manufacturing, warehousing and distribution activities follow Roche quality guidelines.

Primary Responsibilities and Accountabilities:
1. Obtain and maintain approval for manufacturing sites.
2. Monitor local contract manufacturers, warehouses and distributors in accordance with GMP, local regulations and Roche standards.
3. Perform product release and handle for deviation issues.
4. Develop and review Quality System related SOPs, and in charge of SOP deployment
5. Provide QA-related trainings to relevant staff and 3rd parities.
6. Manage return goods.
7. Develop and maintain Quality agreements for all CMO sites
8. Take charge of external QA relevant auditing and visiting
9. Follow-up corrective action plan with contract manufacturers after auditing
10. Ensure the CAPA for Roche Taiwan followed on an audit by PTQG are completed on time.
11. Maintain QA documentation in place
12. Assess QA systems on an ongoing basis to identify opportunities for process improvement
13. Co-ordinate and implement product field actions
14. Provide/update Roche QA requirements/guidance and recommendations to CMOs and ensure the development and implementation at CMO sites for those mandatory requirements.
15. Provide QA guidance and recommendation to business units in the handling of product quality performance
16. Support controlled drug reporting and issue management
17. Support product complaint reporting & management
18. Maintain good knowledge of the relevant Corporate SOP & local regulations
19. Other projects assigned by the Line Manager/supervision

工作條件

  • 工作經歷: 二年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Professional and Technical Requirements --

    Education/Qualifications:
    Bachelor degree of Pharmaceutical or Chemical related

    Strongly desired:
    GMP related qualification

    Experience, Skills, Knowledge:
    1. 2-3 years working experience in pharmaceutical company in QA-related function
    2. 2-3 years working experience in pharmaceutical site is preferred
    3. Knowledge about GMP, QA/QC and related MOHW/TFDA regulation.
    4. Good written English
    5. Good interpersonal/communication skills, ability to interact effectively in a team environment within the functional team and with all cross functions
    6. Familiar in Basic Microsoft Word, Outlook, PowerPoint and Excel

福利制度

1) 勞健保外,另提供完善團保制度
2) 定期健康檢查
3) 彈性福利計畫
4) 年度旅遊補助
5) 員工在職訓練
6) 汽車貸款
7) 股票優惠認購

更新日期:2022-01-04

應徵方式

  • 職務聯絡人: HR
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內6-10人應徵
經歷分佈
新鮮人0%
1~3年10%
3~5年20%
5~10年10%
10年以上60%
學歷分佈
碩士及以上80%
大學20%
專科0%
高中0%
高中以下0%
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