Qualifications (minimum requirements) 任职资格
Education Background: 教育背景
61 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
61 Fluent in written and spoken English
良好的英语书写和沟通能力
Professional Experience专业经验:
61 Minimum 4 years of pharmaceutical QC Lab experience.
至少 4 年制药厂质量控制实验室经验
61 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 sampling of API/Excipients, performing quality control testing of insulin products, excipients and water for pharmaceutical use. In doing so, the chemistry professional will be responsible for activities related to operating laborato-ry equipment, including but not limited to HPLC, AAS, pH meter, UV-VIS, FT-IR, Microscope, Particle Counter, Osmometer, etc. The Chemistry professional will also be responsible for implementing methods of analysis previously established at other NN sites.
作为化学实验室的一员，需进行API/辅料的取样，胰岛素产品、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：HPLC, AAS, pH 计，UV-VIS，FT-IR，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:
61 Perform sampling, sample receiving, Chemicals & Reagents receiving, and register in LIMS.
取样，样品接收，试药、试剂接收和LIMS登记。
61 Perform analysis on samples and report results timely.
执行样品分析，及时报告结果。
61 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制定纠正措施。
61 Perform problem solving related to testing of insulin products, excipients and water for pharma-ceutical use on reruns, deviation etc.
使用再运行，偏差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。
61 Prepare reagents for use in the lab.
实验室试剂配制。
61 Wash glassware.
清洗玻璃仪器。
61 Perform and document all work in accordance with GMP, site, and corporate procedures and poli-cies. Write methods of analysis and other operational documents, translate key operational docu-ments 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。
61 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。
61 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
61 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。