Senior New Product Development Engineer II

    • Qinnan, China

Site Name: Suzhou Plant Tech Industry Park
Posted Date: Oct 22 2019
新产品试验过程
对新产品从原、辅料选择,处方试验、制剂过程开发、包装开发等一系列为达到既定新产品质量、外观要求而进行的系统的工作。主要工作包括:试验用原、辅料的选择;试验方案的制定、执行、跟踪;试验过程关键工艺参数等内容的总结、分析、报告。稳定性评估及稳定性方案制定
注册资料准备
总结注册批生产的批记录;
按照注册要求总结注册批生产前的工艺研究过程以及注册批的工艺过程;
汇总注册部需要的证明性文件(原料合法来源证明等);
审阅递交前注册准备文件的准确性和合理性
新产品项目管理
根据新产品的计划,定期跟踪各项任务的实施情况,根据实施进程的具体情况定期更新时间表,以保证各项目的如期推进或在一定理由的基础上更新时间表。
新产品/新包装上市前准备
负责新产品生产的规模扩大和工艺改进过程的方案设定、实施、跟踪;
规模扩大工艺过程总结;
负责新产品/新包装上市前的项目跟踪协调工作,保证产品顺利上市
遵守公司有关EHS的政策和规定,并完成EHS相关工作。
确保行为符合国家法律、法规政策的要求

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