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General Electric Micro Analyst in Shanghai, China

Job Description Summary

The Micro Analyst will be responsible for performing and reporting of routine analytical tests in the Micro Laboratory according to the specifications; drafting/revising/reviewing SOPs, methods, specifications, training models and IQ/OQ protocol; translating methods; training new analyst and follow-up of the corresponding analyst’s working in the Laboratory.

根据质量标准负责操作及报告微生物实验室的常规分析测试;起草/修改/审阅标准操作规程(SOP)﹑方法﹑质量标准﹑培训讲义和IQ/OQ方案;翻译方法;培训新的分析员及指导实验室内对应分析员的工作。

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

PRIMARY FUNCTIONS

主要职责

Participate in new, corporate and local projects and take part in the validation work throughout the plant, in which Microbiological resources are required.

参与有微生物资源需求的总公司和本厂的新项目,以及验证工作。

Designated analyst shall be responsible for the Microbiological sampling.

指定的分析员对微生物取样赋有职责。

Responsible for the Microbiological sampling testing of utilities/raw materials, in-process samples, semi-finished/finished products, and primary packaging materials testing as well according to designated task.

负责指定的公用工程, 原料,中间控制样品,半成品/成品的微生物取样和测试, 以及内包材的测试。

Designated analyst shall be responsible for the import analysis application in Shanghai Drug Control Institute (SDCI) of all import drugs including API and semi-finished/finished products in compliance with Chinese Regulatory Requirement; contact SDCI for analysis issues.

指定的分析员负责包括活性药物物质和半成品/成品的进口药物在上海市药品检验所的报验工作, 并确保其符合中国法规的规定; 负责与上海市药品检验所联络检测事宜。

Ensure that all the raw data during the testing are correctly recorded down and all results or testing investigation summary are made completely and timely.

确保所有原始测试数据被正确记录,所有结果或测试调查总结能完整并及时地完成。

Ensure that corporate and local EHS procedures are followed.

确保遵循总部和本公司EHS规程。

Responsible for the instrument/equipment management in Microbiological Laboratory , i.e. ensure that each individual instrument/equipment archive be maintained properly with integrated life-cycle documents; updating Laboratory instrument/equipment Calibration Matrix whenever necessary; scheduling monthly calibration and according to Laboratory instrument/equipment Calibration Matrix; ensure that all instrument/equipment Calibration in Laboratory are executed adhering to the schedule; approve Laboratory Calibration Sheet and calibration results; follow-up and ensure the implementation of instrument/equipment IQ/OQ/PQ.

负责微生物实验室仪器/设备的管理,如:确保每个仪器/设备档案在其生命周期里,资料齐全,保存得当;必要时更新仪器/设备校验表;根据仪器/设备校验表制月度计划;确保实验室所有仪器设备校验按计划完成;批准实验室校验主表和校验结果;跟踪并确保仪器/设备的IQ/OQ/PQ的实施。

QUALIFICATION/EXPERIENCE

资历 / 经验

Relevant Science College Diploma or Degree is essential.

相关的理工科大专毕业或相当学历。

Experience from pharmaceutical quality control laboratories and basic knowledge of GMP is desirable.

具备制药业质量控制实验室经验和GMP知识。

Aseptic operation technician is required.

无菌操作技术是必须的。

Knowledge of MS office software is required.

了解MS办公软件。

Basic English knowledge is required.

具备英语技能。

ORGANISATIONAL SITUATION

组织形式

The analyst reports to Microbiological laboratory manager.

该分析员向微生物实验室经理汇报工作。

If the Microbiological Laboratory Analyst is absent, other Analyst shall substitute him/her in Chemistry Lab. As a consequence, the Analyst may also substitute a person with similar or lower competence if needed or instructed by the superior.

如果该微生物分析员缺席,具备同等或较高能力和资格的人员可替代。同样,如果技术资格符合要求,该分析员也可替代同等或较低要求的职位。

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

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