职位描述
POSITION SUMMARY（职位概述）
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.
按照控制计划/SOP要求计划、执行及记录原材料、产品、水系统及其他化学分析/测试。主要负责确保化学分析操作符合BD/ISO/法规/GMP要求。
KEYRESPONSIBILITIES（主要职责）
1. All chemical test required by product release, periodical inspection, validation, project and other requirements:
产品放行、周期测试、验证、项目及其他需要的化学测试
- EO residue batch wise test with GC气相色谱仪方法执行EO残留量放行测试- Chemical analysis as specified by control plan/SOPs控制计划/SOP规定的化学分析- Water monitoring test水系统监测- Other chemical analysis as validation required, or product registration required, and notify body requirements.
其他验证、产品法规、认证机构要求的化学分析
- Documentation for all executed chemical analysis 记录所有的化学测试操作- OOS investigation regarding chemical test有关化学分析的超限度分析- Chemical instrument PM and maintain validation status化学测试设备的预防性维护及验证状态维护
2. Chemical reagent control as per GMP rule
根据GMP规则控制化学试剂
3. Toxic chemical control as per police and EHS standard
根据政策及EHS标准控制有毒化学品
4. Chemical analysis techknowledge upgrade/application per regulation/BD requirements.
根据法规和BD要求更新及应用化学分析技术
5. Support the head of micro lab for lab management in lab competency improvement
协助微生物实验室负责人管理实验室以提高实验室能力
- lab documents addressing data integrity
实验数据完整性
- chemical knowledge sharing with team
分享化学知识
- 5s compliance
5s 符合
- timing management and efficiency
时间管理及效率
6. other tasks assigned by manager, lab head.
其他QA经理及实验室负责人指派的工作
SKILLSANDABILITIES（技能）
1. Above bachelor degree of chemistry, or relevant.
化学相关专业本科或以上学历毕业；
2. 3 years’ experience for chemical analysis with familiar with GC/workstation, UV , TOC and classic chem. Tests in a QC lab .
气相色谱仪、紫外风光光度仪、总有机碳仪及一般化学测试相关工作经验3年以上；
3. GMP/ISO13485 knowledge as basic for the role
具备GMP/ISO13485相关基本知识
4. Good communicate and learning skill.
良好的沟通技巧、学习能力；
5. Skill of Micro office .
电脑办公软件应用熟练；
6. Skill of English in reading and writing.
有一定的英语读写能力。
7. With or be trained Pressure Vessel Operation Certificate preferred
持有压力容器操作证，或经相关培训优先。
