Specialised Knowledge 专业知识:
- 文化程度(学历/专业) education background
college degree, pharmacy or related special
- 任职经验job experience
- 专业知识/技能professional knowledge
familiar with QMS
Familiar with government and local regulation(GMP,GLP, medical device, SFDA)
Familiar with drug analysis, analytical equipment and new drug specification
Familiar with specification, cCNP USP,EP
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
Strongly learn, analysis and innovate ability
Agility to receive new technology
Job Purpose 岗位目的:
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.
Correctly finish all testing of materials, bulk and finished product, analytical report.
Comply with all cGMP/GLP /medical device regulations to ensure data accuracy
Support analytical technical improvement and method implementing, support lab management improvement.
Finish new kind of incoming materials and source change materials testing, provide technical support for new product registration.
Review and revise SOP.
Responsible for the instrument maintenance and simple calibration.
To comply with QMS and GQMP requirement as assigned, and participate & support the execution of site Quality plan
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.
You may apply for this position online by selecting the Apply now button.
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