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Biology Professional III
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The position
Be the responsible for set up Biology method transfer and related validation 负责生物实验的转移和验证 Perform analysis on samples and related operations, report results timely. 执行样品分析和相关操作，及时汇报结果 Support Investigation of out –of-specification (OOS) results and implement corrective actions when required. 当需要时，支持调查超标结果并执行纠正行动。 Involve in performing problem solving related to testing of drug products and Drug Substance for pharmaceutical use on reruns, deviations, etc. and support cross Dept. problem solving.参与解决与产品和原料药检测的再测试、等问题并支持跨部门的问题解决。
Implement Control Chart and conduct trend analysis according to NN requirement.按照诺和诺德要求为定量测试执行控制图及趋势分析。
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.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，翻译关键操作文件。
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 。Qualifications
4-yr (BS) Degree in Biology, Pharmacy, or related field.生物学、药学或其他相关领域学科 4 年本科教育学士学位
Good communication skill and culture understanding良好的沟通能力和文化认可
Good at English, both verbal and written良好英文口语及写作能力
Minimum 5 years of pharmaceutical QC Biology Lab experience 至少 5 年制药厂质量控制生物实验室工作经验 Previous experience with setting up Biology method according to pharmacopoeia methods for product analysis is desirable 具有依据药典建立产品生物分析方法的经验