规范工程师岗位职责.docx
规范工程师岗位职责 标准工程师 四川科伦药业股份有限公司安岳分公司 四川科伦药业股份有限公司安岳分公司(分支机构) 岗位职责: 1、 负责并主持GMP监视执行工作,根据GMP标准要求,负责化药车间、中药车间和创新车间的标准生产治理工作,按经批准的工艺规程和生产操作规程生产,监视检查其生产和质量掌握过程; 2、 负责国家现行药品相关法律法规和政策及公司文件制度的严格执行,组织实施GMP的监、帮、促工作; 3、 负责组织实施GMP系统文件的编制、修订,确保系统文件的法规符合性、有用性和可操作性; 4、 协作行政人事部组织国家药品法律法规、公司文件制度更新的准时培训以及员工转岗、离岗和新员工岗前培训考核工作; 5、 参与质量部组织的质量分析会议及GMP相关活动,对生产过程中所发生的偏差、变更、验证等标准治理负责; 6、 公司GMP自检和确认与验证工作。 任职要求: 1、40岁以下,药学或相关专业全日制本科以上学历,具有至少三年从事口服固体制剂药品生产和质量治理阅历; 2、责任心强,心态积极,具有较强的领导力量、承压力量;有解决突发大事的力量、时间治理力量,可独立主持处理事务。 3、熟识GMP学问及药品生产的相关学问、法规,有新版GMP认证阅历; 4、具备FDA认证、欧盟GMP认证阅历和六西格玛治理阅历优先; 5、娴熟运用计算机,具备良好的书面表达力量。 篇2:内饰工程师岗位职责 内饰工程师 Minimum bachelor degree in engineering or equivalent qualification · Minimum 5 years experience in experience interior development (must have experience in IP and Greenhouse system) · Minimum 1 complete new development project experience · Minimum 1 complete localization project experience · Project management experience required · Basic knowledge on CATIA and PLM tool · Teamwork and communication skills, conceptual and analytical skills, structured work-wise and sovereign and confident manner in an international environment · Good skills in oral and written English, French is an add on, Chinese as mother tongue · Main work location at Shenyang city, with frequent travelling Main Tasks Responsibility 主要任务和职责 · Control of projects focusing on interior system from the development phase through to series production se · Guide the process chain for achieving the project objectives in terms of function, quality, deadlines and costs · Coordination with the shopping, the plants, suppliers and other interface partners · Preparation of specifications and risk analysis · Release and change management · Documentation of project progress and presentation in the bodies Minimum bachelor degree in engineering or equivalent qualification · Minimum 5 years experience in experience interior development (must have experience in IP and Greenhouse system) · Minimum 1 complete new development project experience · Minimum 1 complete localization project experience · Project management experience required · Basic knowledge on CATIA and PLM tool · Teamwork and communication skills, conceptual and analytical skills, structured work-wise and sovereign and confident manner in an international environment · Good skills in oral and written English, French is an add on, Chinese as mother tongue · Main work location at Shenyang city, with frequent travelling Main Tasks Responsibility 主要任务和职责 · Control of projects focusing on interior system from the development phase through to series production se · Guide the process chain for achieving the project objectives in terms of function, quality, deadlines and costs · Coordination with the shopping, the plants, suppliers and other interface partners · Preparation of specifications and risk analysis · Release and change management · Documentation of project progress and presentation in the bodies
