任职要求/岗位职责

负责分析方法和标准的建立和维护，方法验证，转移和确认及方法的周期性回顾。

Responsible for analytical method creation and maintenance, method validation, transfer, verification and periodic review.

相关文件的撰写，如实验方法，SOP，验证文件等。

Prepare associated documents such as Test Method, SOP, validation protocol and report etc.

根据相关的SOP或标准测试方法执行日常必须的测试，包括中间体和成品的放行和稳定性测试，清洁验证测试。

Perform the necessary tests including intermediate and drug product release test, stability test and cleaning validation test according to the relevant SOP/Test Methods.

执行OSD理化实验室的偏差、OOS/OOT/OOE和实验室事件的调查，执行CAPA。

Perform investigation of deviation and OOS/OOT/OOE and lab events, as well as CAPAs within OSD chemical lab.

必要时参与偏差调查活动并提供相关技术支持。

Carry out the deviation investigation and provide the technical support as required.

如需要，培训检验人员。

Provide training to other analysts if required.

承担个人安全职责，保护自己，并避免伤害他人和环境。参加该岗位的必须的安全培训并配合应急预案的演练。

Take personal safety responsibility, protect yourself and avoid hurting others and the environment. Participate in the necessary safety training for the post and cooperate with the drill of emergency plan.

严格执行岗位安全操作规程。及时汇报工作中的任何事故事件和危险源。

Strictly follow EHS procedure. Report any EHS accident and hazard in a timely manner.

其他管理层安排的任务

Other work from lab management

工作要求：

本科或以上学历，药学，生物学或化学专业

Bachelor or above degree in Pharmacy, Biology or Chemistry

在制药领域具有综合的化学和仪器专业知识，包括理化测试，HPLC，GC，验证等

Comprehensive knowledge of chemical and instrument testing, including physical and chemical examinations, HPLC, GC, validation, etc. in Pharmaceutical industry

了解制药行业的质量体系，GMP和药典的要求

Knowledge of Quality System, international GMP and Pharmacopeias in Pharmaceutical industry

制药或相关行业3年以上分析工作经验

3 years or more work experience as analyst roles in Pharmaceutical industry or associated industries.

能用英语读写，会熟练使用电脑

Read and write in English and good computer skill

OSD QC理化分析师（AS&T）