職位描述
工作職責:
1. 日常測試Routine test
-對原輔料，包裝材料，中控樣品，成品和穩定性研究樣品等進行化學測試并按GMP要求及時完成相關檢驗記錄. Perform chemical tests for raw materials, packaging materials, in-process samples, finished products and stability samples; finish testing record and logbook on time per GMP requirement.
- 潔凈介質（純化水、注射用水、純蒸汽、氮氣等）的檢測 Tests for purified water, WFI, pure steam, nitrogen, etc.
- 工藝驗證、清潔驗證、投訴樣品、偏差調查等的測試 Tests for process scale-up, cleaning validation, invetigation, etc.
- 供應商開發等小樣測試 Assigned other tasks, such as new vendor development
2. GMP/EHS 合規 GMP & EHS Compliance
- 實驗室文件系統和數據庫的維護 Maintain documetation system and data base;
- 根據中國藥典/歐洲藥典和貝朗總部的要求起草相關SOP和 質量標準 Generate SOP, Speciffications per ChP, Ph. Eur. and B
Braun Global
s requirement
- 實驗相關的配制記錄、儀器使用記錄的及時填寫 Ensure logbook and record are finished in a timely manner;
- 遵守公司EHS 要求進行實驗操作 Follow the EHS requirement;
- 日常5S管理 Lab 5S managment
3. 日常輔助工作 Lab routine management support
- 實驗室試劑、耗材的使用與管理 Routine management of reagents, consumbles;
- 對照品使用、滴定液標定、留樣、穩定性實驗等實驗室日常管理 Routine management of reference standards, volumetric solution, retention samples, stability samples, etc.
- 實驗室儀器設備的日常維護保養與確認 Maintainenance, qualification of lab instruments;
- 待檢樣品的接收與確認 Reception and managment of incoming samples
4. 完成主管分配的其它任務 Other tasks assigned by direct supervisor
- 團隊內部技術分享 Internal sharing;
- 帶教新員工培訓 Provide on job training for new employee;
- 跨事業部測試服務 Provide testing support during cross functional cooperation
任職資格:
College degree or above. Major on pharmaceutical or related.
大專及以上學歷，藥學或相關專業。
Have basic knowledge of chemical analysis,familiar with ChP, GMP, ICH.
具有化學分析的基礎知識，熟悉ChP/GMP/ICH。
ability to read English and good computer skill.
良好的英語讀寫能力和電腦操作能力。
More than 1 years of related experience in the pharmaceutical industry .
1年以上醫藥行業相關工作經驗。
Good communication and oral delivery in logic and knowledgeable way
良好的口頭邏輯溝通能力
In plant and travel based on business needs
在工廠能隨業務需要出差
