- 负责由本厂生产的新产品项目管理，特别是工艺转接的技术指导，以保证在符合GMP规范下本厂生产新产品的成功报批和生产转化. Be responsible on projects management on new products with own manufacturing approach, especially on technical transferring process, as to get projects MA granted and manufacture conversion with GMP and related Regulatory compliance. 主要工作职责 Specific Job Responsibilities 1.贯彻执行国家相关药政法规，依法主持新产品开发工作。Initiate new product technical development under strict compliance with Regulatory and GMP. 2.积极推动EHS政策和质量方针的实施，对本部门的人员和生产安全负全部责任Execute EHS policy and Quality policy，responsible for departmental staffs production safety 3.参与新产品立项中本厂生产的项目评估，特别是处方工艺技术合理性和可行性的评估 Participate assessment process of own manufacturing new projects, especially on reliability and feasibility of technical process 4.由本厂生产的新产品项目确立后，负责项目行动方案的计划、项目小组的成立和分工及协调 When new project with own manufacturing approach initiated, responsible on project master planning , project team establishment, task deployment 5.负责对新产品、新工艺、新材料、新设备的试验和使用 In charge of trial and testing work for new products, new technical, new material and new equipment; 负责新产品试制及相关报批材料准备, 负责产品新内包材的选择与评价Prepare for new products’ manufacturing and declare material, select and value packaging material for products.; 根据生产计划编制物料需求计划，安排生产作业进度，按GMP规范组织生产Draft out material demand plan base on production planning, follow and arrange production schedule, comply with GMP;编写和修订与新产品开发相关GMP文件。审核新产品的生产工艺规程 Review and carry out technical process documentation of new products 6.负责对新引入API 的MSDS 数据搜索及风险评估，提供清洗方法及主持引入生产的清洗验证工作。 Risk analysis of new API introduction and offer cleaning method and organize cleaning validation on production 7.负责与项目相关的注册部和品质部人员的沟通和协调 Communicate and coordinate with project related RA and Validation team 8.负责调控项目预算，合理控制研发费用 Budget controlling and keep saving 9.负责项目组成员的业绩考核 In charge of appraisal of project team staffs 10.确保在上岗前已得到与该职位相关符合GMP要求SOP培训 Follow GMP and SOP training before staffs on post 11.医药情报资料的收集、整理、分析工作Collect pharmaceuticals information and analyze 12.上级临时指派的任务 Functional support to line manager for temporary tasks 要求： 大学本科以上，制药药学类或相关专业、有一定的英语水平 相关工作六年以上，有较强的协调、管理和沟通能力，认真、细致、严谨。 有较强的责任心和奉献精神。 熟悉工艺生产流程，具备较强的产品研发创意、数据分析、断能力与决策能力、协调沟通能力 熟悉药事法规 良好的电脑操作技能，能熟练应用。