職位描述
POSITION SUMMARY（職位概述）
Plan and conduct chemical analysis/test and documentation required by control plan/SOPs for raw materials, finished product, water system, and other necessary. Take main responsibility for chemical analysis relevant implemented to meet BD/ISO/GB/regulation/GMP requirements.
按照控制計劃/SOP要求計劃、執行及記錄原材料、產品、水系統及其他化學分析/測試。主要負責確保化學分析操作符合BD/ISO/法規/GMP要求。
KEYRESPONSIBILITIES（主要職責）
1. All chemical test required by product release, periodical inspection, validation, project and other requirements:
產品放行、周期測試、驗證、項目及其他需要的化學測試
- EO residue batch wise test with GC氣相色譜儀方法執行EO殘留量放行測試- Chemical analysis as specified by control plan/SOPs控制計劃/SOP規定的化學分析- Water monitoring test水系統監測- Other chemical analysis as validation required, or product registration required, and notify body requirements.
其他驗證、產品法規、認證機構要求的化學分析
- Documentation for all executed chemical analysis 記錄所有的化學測試操作- OOS investigation regarding chemical test有關化學分析的超限度分析- Chemical instrument PM and maintain validation status化學測試設備的預防性維護及驗證狀態維護
2. Chemical reagent control as per GMP rule
根據GMP規則控制化學試劑
3. Toxic chemical control as per police and EHS standard
根據政策及EHS標準控制有毒化學品
4. Chemical analysis techknowledge upgrade/application per regulation/BD requirements.
根據法規和BD要求更新及應用化學分析技術
5. Support the head of micro lab for lab management in lab competency improvement
協助微生物實驗室負責人管理實驗室以提高實驗室能力
- lab documents addressing data integrity
實驗數據完整性
- chemical knowledge sharing with team
分享化學知識
- 5s compliance
5s 符合
- timing management and efficiency
時間管理及效率
6. other tasks assigned by manager, lab head.
其他QA經理及實驗室負責人指派的工作
SKILLSANDABILITIES（技能）
1. Above bachelor degree of chemistry, or relevant.
化學相關專業本科或以上學歷畢業；
2. 3 years’ experience for chemical analysis with familiar with GC/workstation, UV , TOC and classic chem. Tests in a QC lab .
氣相色譜儀、紫外風光光度儀、總有機碳儀及一般化學測試相關工作經驗3年以上；
3. GMP/ISO13485 knowledge as basic for the role
具備GMP/ISO13485相關基本知識
4. Good communicate and learning skill.
良好的溝通技巧、學習能力；
5. Skill of Micro office .
電腦辦公軟件應用熟練；
6. Skill of English in reading and writing.
有一定的英語讀寫能力。
7. With or be trained Pressure Vessel Operation Certificate preferred
持有壓力容器操作證，或經相關培訓優先。
