Lab Analyst

Basic qualifications:

Specialised Knowledge 专业知识:

  • 文化程度(学历/专业) education background

大专以上,药学或相关专业毕业;

college degree, pharmacy or related special

  • 任职经验job experience

No requirement

  • 专业知识/技能professional knowledge

熟悉QMS

familiar with QMS

了解国家和地方质量政策法规(GMP,GLP,医疗器械,药监,药检等)

Familiar with government and local regulation(GMP,GLP, medical device, SFDA)

熟悉相关药物分析方法,仪器使用及新药标准方面的知识

Familiar with drug analysis, analytical equipment and new drug specification

熟悉公司相关质量标准/规程,现行CP和国际通用标准如USP,EP

Familiar with specification, cCNP USP,EP

具备基础化验仪器使用知识,具有化验或相关证书

Certificate with analysis basic knowledge and qualified

  • 计算机及外语水平computer and language

良好的电脑及业务软件的使用能力Good computer software operation skills

英语水平较好Good English oral and writing skills.

  • 能力要求/basic requirement

较强的学习能力,分析和创新能力

Strongly learn, analysis and innovate ability

具有接受新技术的能力

Agility to receive new technology

Preferred qualifications:

N/A

Details:

Job Purpose 岗位目的:

负责TSKF相关原辅料,半成品,成品化验。负责工艺及清洁验证的化验支持,支持分析技术及分析方法改进,协助实施实验室管理改进。负责新产品小试物料化验支持。回顾与修订SOP, 对所使用的仪器进行日常校正维护及简单的故障排除。

Be responsible for testing of materials, bulk and finished product; also in charge of process validation and cleaning validation testing; support analytical technical improvement and method implementing; provide support of new materials testing; review and revise SOP; Able to handle instruments, including basic calibration, maintenance and troubleshooting.

Key Responsibilities主要岗位职责:

1.在规定规程和时间内准确无误地完成原辅料,半成品,成品分析检测,完成化验报告;

Correctly finish all testing of materials, bulk and finished product, analytical report.

2.执行所有相关规程,确保分析数据的准确,符合cGMP/GLP/医疗器械法规的要求;

Comply with all cGMP/GLP /medical device regulations to ensure data accuracy

3.支持分析技术及分析方法的改进,协助实施实验室管理改进;

Support analytical technical improvement and method implementing, support lab management improvement.

4.完成新产品小试阶段原辅料, 货源变更等新物料进厂检验,为新产品报批提供必要的技术支持;

Finish new kind of incoming materials and source change materials testing, provide technical support for new product registration.

5.回顾与修订SOP。

Review and revise SOP.

6.对所使用的仪器进行日常维护及简单的校正。

Responsible for the instrument maintenance and simple calibration.

7.在职责范围内遵守QMS和GQMP及法规的要求,参与和支持工厂质量计划的执行。

To comply with QMS and GQMP requirement as assigned, and participate & support the execution of site Quality plan

8.理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、葛兰素质量管理体系及环境健康安全等方面的标准和公司方针,遵守公司标准操作规程。

Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.

Contact information:

You may apply for this position online by selecting the Apply now button.

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