【主要职责-Key Responsibility】
QA专员主要协助和支持各位专家及顾问开展GMP相关的项目，这里，您可以全面接触各类项目，并逐步积累工作和项目经验，为进一步的职业发展夯实基础。
Assist Experts for executing GMP relevant projects. Here, you will accumulate the working and project experience by participating different projects, which is helpful for consolidating the foundation of career development.

【职位描述-Job Description】
1. 收集、更新制药及其他生命科学行业相关的法规要求；
2. 根据最新的法规要求和实际操作，支持编写GMP文件，包括质量管理、实验室管理、生产管理、物料及仓储管理、设施及设备管理等；
3. 根据项目需求，协助翻译相关GMP文件；
4. 支持专家参与各类审计项目，如无菌、制剂、原料药、包材及辅料审计；
4. 协助准备培训材料，协助跟踪项目进展，配合客户完成工作；
5. 其它安排的项目工作。
Ⅰ Collect and update the regulatory requirements related to pharmaceutical and other Life Sciences industries.
II Support preparating GMP SOPs according to the latest regulatory requirements and actual practices, i.e. Quality Management, Lab Management, Manufacture Management.
III Assist in translation GMP documentation.
IV Support audit execution, including: sterilization, drug, API, package, etc.
V Assist in preparing training document and follow up the project procedure, reach client’s requirements.
Ⅵ Other duties as assigned.

【任职要求-Expectation】
1. 药学、制药工程、化学和生物科学等相关专业；
2. 具备药品质量和生产相关专业知识，熟悉海外和中国GMP等法规相关知识；
3. 至少四年制药工厂质量保证/管理部门工作经验；*必须
4. 有质量体系建立经验者优先考虑；
5. 良好英语阅读和书写能力。
Ⅰ Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.
II Pharmaceutical knowledge in quality or manufacturing of drugs. Familiar with overseas and Chinese GMP regulations is preferred.
III Minimum of 4 years plant QA experience in pharmaceutical industry. *kindly note that year of working experience is essential.
IV Experiences on quality system establishment is preferred.
V Good knowhow in English reading and writing.