主要责任 Key responsibilities 86 为生产开发高效和完善的工艺;提供原始文件,结果评估。 Develop efficient and robust processes for the manufacture. Provide raw data documentation and result evaluation. 86 优化现有的方法(实验室、中试车间或者生产)并且开发更多有效的方法。 Optimize existing methods (lab, pilot plant or production) and develop more efficient ones. 86 建立实验室流程、报告和相关的标准操作流程。 Generate lab procedures, reports and related SOP’s. 86 负责工艺转移,验证至中试车间或者生产,包括故障排除、中控等。 Be responsible to process transfer, validation, production to pilot plant or production unit , including troubleshooting, in process controls etc. 86 书写生产流程并以此对操作团队进行培训。 Write Manufacturing Procedures and train manufacturing team based on manufacturing procedure. 86 负责生产批记录的审核。 Responsible to perform batch record review. 86 建立相关的项目文档(项目经验报告、费用估算、注册文件等)。 Establish appropriate campaign documentation (campaign experience report, cost estimation, registration documentation etc). 86 参与GMP或FDA认证的相关工作 Participate in the authentication for GMP and FDA 61 对偏差和安全问题进行调查和根本原因分析 Investigate and root cause analysis of deviation and safety issue
主要经验和技能 Critical Experience and Skills 61 硕士及以上学历,有机化学专业优先 Master degree or above in organic chemistry is preferred. 61 2年以上化工行业工艺研发的工作经验为优 2 or more years of process research and development experience in the chemical industry is preferred. 61 英语良好 Good English skill.