Typical Accountabilities
主要职责
Specific Responsibilities/Tasks
Routine work 日常工作
Finish the routine analytical work accurately and timely
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Issue the analytical method transferring and validation protocol for raw materials finish products etc.,
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Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status.
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Double-checking the BAR.
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Responsible for the management of chemical reagents/ reference standard/ consumables, including purchase and maintenance of safety inventory
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Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances
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Keep the chemical lab tidy and clean at any time.
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Report any deviation timely, lead major deviation/OOS investigation
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Stability study management
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Issue and revise specification, test method and batch analysis record of starting materials and finished products, and purchasing specification, test method for PQ, CQ etc.
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Prepare specification for application (draft) and specification explanation
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Maintenance of QC E-system eg. GQCLIMS,1Lab, Empower
/Empower
New employee training
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Issue technical assessment report
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Lead team level CI project
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S.H.E. Responsibilities
SHE 职责
Take personal responsibility for security to protect themselves and avoid harm to others and the environment
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Participate the necessary security training and drills with the contingency project
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Strictly enforce the job safety procedures
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Report any incidents , accidents and hazards in work timely
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Purchase/ store/ use controlled chemicals.
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GMP compliance
GMP 符合性
Strictly following SOP and Guideline
严格执行岗位操作规程和指南
Take GMP training and strictly following GMP compliance
参加GMP培训,严格遵守GMP与法规要求
Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.
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Take part in actively in correction to the observations found in self-inspection.
积极参加对自检中所发现缺陷的整改
Training and development
培训和发展
Participate actively in serials training required to be held by internal and external.
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Develop all kinds of skills in relation to work field and pursue continuous improvement
发展各种工作技能并追求持续的改进
Others
其他
Assist the senior engineer in completing tasks when required.
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Complete other tasks arranged according to business needs
根据业务需要完成安排的其他工作
Qualifications资质
Education, Experience and Training
教育、工作经验和培训
Education, Experience and Training
教育、工作经验和培训
Academic / Professional qualification 学历/专业资格
Bachelor or above 本科或以上学历
Technical / skills training 技术/技能训练
Basic GMP, GLP knowledge; Experience in QC 基本的GMP, GLP知识及QC经验
Working experience 工作经验 (No. of years / 年 资, Job function /工作功能, Business types /业务种类 )
Essential 必需
More than 4 years working experience in pharmaceutical company or related industry