Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

• 4-yr (BS) D Degree in Chemistry, Pharmacy, Engineering or related field
化学、药剂学、工程学或其他相关领域学科4 年本科教育学士学位

• Fluent in written and spoken English
良好的英语书写和沟通能力

Professional Experience专业经验:

• Minimum 7 years of pharmaceutical QC Lab experience.
至少7 年制药厂质量控制实验室经验

• Previous experience with analysis of water for pharmaceutical use desirable
具有制药用水分析的工作经验

Job content工作内容描述

Key areas of responsibility 主要工作职责:

The chemistry professional works as part of a team is responsible for performing quality control testing of insulin products and related in-process/Auxiliary solution, be familiar with quality testing of excipients and water for pharmaceutical use. In doing so, the chemistry professional will be responsible for activities related to operating laboratory equipment, including Laboratory balance, pH meter, HPLC, AAS, UV-VIS, Microscope, Particle Counter, OsmoTouch, etc. The Chemistry professional will also be responsible for implementing methods of analysis previously established at other NN sites.
为化学实验室的专员，需进行胰岛素产品以及相关中间/辅助溶液的测试，并熟悉辅料和制药用水的测试。在此情况下，化学实验室专员将负责操作实验室设备，包括但不限于：天平，pH计，高效液相色谱仪，原子吸收分光光度计，紫外分光光度计，显微镜，粒子计数器，渗透压测定仪等。化学实验室专员也将负责实施已在其他诺和诺德生产厂建立的分析方法。

Main Job Tasks 主要工作任务:

• Perform analysis on samples and report results timely.
执行样品分析，及时报告结果。

• Investigate out –of-specification (OOS) results and implement corrective actions when required.
当需要时调查超出标准结果和纠正措施。

• Perform problem solving related to testing of insulin products, excipients and water for pharmaceutical use on reruns, deviation report etc .
用再运行，偏差报告等方式来解决化学实验室在胰岛素产品、辅料和制药用水相关实验的问题。

• Prepare reagents for use in the lab
实验室试剂配制。

• Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write methods of analysis and other operational documents, translate key operational documents from English into Chinese.
所有操作和记录文件符合GMP、工厂和公司流程政策。编写分析方法和其他操作文件，将关键操作文件的英文版本翻译成中文。

• Be familiar with general requirements in Pharmacopeia; Prepare analytical procedure according to Pharmacopeia; Identify the gap of local procedure and Pharmacopeia; Deep understanding of guidelines of Pharmacopeia.
熟悉药典通用要求；可以按照药典编撰分析方法；分析现有分析方法和药典之间的差异；深入了解药典的指导方针。

• Train other end users to operate equipment and to execute methods of analysis.
培训其他最终用户如何操作设备和进行实验。

Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations.
维护安全的工作环境并且按照所有诺和诺德和中国当地安全和环境法规工作。

Other individual assignments 其他工作任务:

• As internal SME for Insulin Test, aim for process implementation and optimization, support for Audit issue.
作为胰岛素测试的内部SME，致力于流程执行、优化及审计相关工作。

• As LI supervisor, head LIs in QCC, ensure scientific investigation and effective actions. 作为实验室调查主导人，主导实验室调查，确保调查充分、行动有效。

• As reviewer for Insulin, Excipient and water testing, highly ensure all of the related testing is in compliance with quality components.
作为胰岛素、辅料与水检测的复核人员，高度确保相关检测符合质量要素的要求。

其他信息

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