职位描述
工作职责:
1. 日常测试Routine test
-对原辅料，包装材料，中控样品，成品和稳定性研究样品等进行化学测试并按GMP要求及时完成相关检验记录. 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.
- 洁净介质（纯化水、注射用水、纯蒸汽、氮气等）的检测 Tests for purified water, WFI, pure steam, nitrogen, etc.
- 工艺验证、清洁验证、投诉样品、偏差调查等的测试 Tests for process scale-up, cleaning validation, invetigation, etc.
- 供应商开发等小样测试 Assigned other tasks, such as new vendor development
2. GMP/EHS 合规 GMP & EHS Compliance
- 实验室文件系统和数据库的维护 Maintain documetation system and data base;
- 根据中国药典/欧洲药典和贝朗总部的要求起草相关SOP和 质量标准 Generate SOP, Speciffications per ChP, Ph. Eur. and B
Braun Global
s requirement
- 实验相关的配制记录、仪器使用记录的及时填写 Ensure logbook and record are finished in a timely manner;
- 遵守公司EHS 要求进行实验操作 Follow the EHS requirement;
- 日常5S管理 Lab 5S managment
3. 日常辅助工作 Lab routine management support
- 实验室试剂、耗材的使用与管理 Routine management of reagents, consumbles;
- 对照品使用、滴定液标定、留样、稳定性实验等实验室日常管理 Routine management of reference standards, volumetric solution, retention samples, stability samples, etc.
- 实验室仪器设备的日常维护保养与确认 Maintainenance, qualification of lab instruments;
- 待检样品的接收与确认 Reception and managment of incoming samples
4. 完成主管分配的其它任务 Other tasks assigned by direct supervisor
- 团队内部技术分享 Internal sharing;
- 带教新员工培训 Provide on job training for new employee;
- 跨事业部测试服务 Provide testing support during cross functional cooperation
任职资格:
College degree or above. Major on pharmaceutical or related.
大专及以上学历，药学或相关专业。
Have basic knowledge of chemical analysis,familiar with ChP, GMP, ICH.
具有化学分析的基础知识，熟悉ChP/GMP/ICH。
ability to read English and good computer skill.
良好的英语读写能力和电脑操作能力。
More than 1 years of related experience in the pharmaceutical industry .
1年以上医药行业相关工作经验。
Good communication and oral delivery in logic and knowledgeable way
良好的口头逻辑沟通能力
In plant and travel based on business needs
在工厂能随业务需要出差
