Engineer/Ass. Engineer, Analytical
AstraZenecaChina - wuxiUpdate time: August 27,2021
Job Description

•      Finish the routine analytical work accurately and timely

准确及时地完成日常分析工作   

•      Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status.

按计划定期做好仪器的维护和验证工作并使其处于良好状态。

•      Double-checking the BAR.

复核批化验记录

•      Responsible for the management of  chemical reagents/ reference standard/ consumables, including purchase and maintenance of safety inventory

负责化学试剂/对照品/易耗品的管理包括采购及维护安全库存

•      Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances

负责实验室废弃物品/过期试剂/剧毒品的处理和处置

•      Keep the chemical lab tidy and clean at any time.

保持化学室在任何时候的整齐和清洁

•      Report any deviation timely and assist in investigation

及时报告偏差和协助调查

•      Stability study and test

稳定性研究和试验

•      Equipment & Column routine maintenance

仪器和色谱柱日常维护

•      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.

制(修)定原辅料、成品的质量标准、检测方法和批化验记录,原辅料采购标准,工艺验证和清洁验证检测方法

•      Prepare specification for application (draft) and specification explanation

起草申报质量标准草案和起草说明

•      Check specification and test method for import products together with Regulatory department

协助法规部有关进口药品的质量标准复核工作

•      Maintenance of QC E-system eg. GQCLIMS, E-lab, Empower

负责实验室系统中数据维护,如GQCLIMS/E-Lab/Empower

•      Technology transfer and method validation/verification

              技术转移和分析方法验证/确认

•      Follow related SOPs and regulations strictly in chemical lab.

严格执行化学室的相关标准作业程序和规章制度

•      Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.

及时按照SOP的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性

•      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

•      Participate actively in serials training required to be held by internal and external.

积极参加由内部或外部组织的系列培训活动。

•      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

•      Coach the new employee and carry out training to them.

辅导新员工并做好相关培训

•      Update of SOPs when required.

需要时,更新SOP

•      Assist in engineer’s works when required.

协助分析工程师的工作

•      Finish other work assigned by group leader

    完成团队主管交办的其它工作

Date Posted

26-8月-2021

Closing Date

07-10月-2021

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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