DP 15 制剂工程师-运营

基本要求： Basic Requirement： 专科或本科，生物，化学工程，食品，制药，计算机，统计相关专业 Specialty or Bachelor degree in biology, chemical engineering, food, pharmaceutical, computer, statistical science related specialty。 专科：8年以上专业领域经验 Specialty: Over 8 years of experience in a specialty area 本科：5年以上专业领域经验 Undergraduate: Over 5 years of experience in a specialty area 任职要求： Professional Skills： 熟悉药物GMP生产流程及质量流程，熟悉质量文件的撰写和流程，包括：CAPA、CC、SOP、Memo等；精通SAP、MDG等物料管理系统； Familiar with the GMP production process and quality procedures, including the preparation of quality documents such as CAPA, CC, SOP, and Memo; proficient in material management systems like SAP and MDG; 精通办公自动化软件MS-Office； Proficient in MS-Office office automation software; 如熟悉GMP文件管理系统MasterContro，质量事件追踪系统TrackWise为佳 Familiarity with GMP document management systems such as MasterControl and quality event tracking systems like TrackWise is highly recommended 有较强的跨组跨部门沟通协调能力，组织任务推动能力 Possesses strong cross-group and cross-departmental communication and coordination skills, as well as the ability to organize and drive task execution

1. 01

   负责生产任务的班次协调和排班 Responsible for shift coordination and scheduling of production tasks

2. 02

   负责车间物料暂存及接收、退库、投诉等管理，负责项目物料的调拨、需求整理、预警等，能够熟练使用SAP系统进行生产批次的物料管理 Responsible for the temporary storage, receipt, return, and complaint management of workshop materials, as well as the allocation, demand organization, and early warning of project materials. Proficient in using the SAP system for production batch material management

3. 03

   负责生产人员的资质管理和培训协调，GMP人员的资质更新、培训任务的安排和追踪，确保生产人员获取对应的资质 Responsible for the qualification management and training coordination of production personnel, as well as the qualification renewal, task arrangement, and tracking of GMP personnel, ensuring that production personnel obtain the corresponding qualifications

4. 04

   负责组内GMP文件的管控、流转、保存、归档、追踪记录 Responsible for the control, circulation, storage, archiving, and tracking records of GMP documents within the team

5. 05

   负责组内质量事件的追踪、记录（包括偏差、变更、审计发现项等） Responsible for tracking and documenting quality incidents within the team (including deviations, changes, audit findings, etc.)

6. 06

   负责定期向部门更新、汇报生产状况 Responsible for regularly updating and reporting production status to the department

Basic Requirement： 专科或本科，生物，化学工程，食品，制药，计算机，统计相关专业 Specialty or Bachelor degree in biology, chemical engineering, food, pharmaceutical, computer, statistical science related specialty。 专科：8年以上专业领域经验 Specialty: Over 8 years of experience in a specialty area 本科：5年以上专业领域经验 Undergraduate: Over 5 years of experience in a specialty area 任职要求： Professional Skills： 熟悉药物GMP生产流程及质量流程，熟悉质量文件的撰写和流程，包括：CAPA、CC、SOP、Memo等；精通SAP、MDG等物料管理系统； Familiar with the GMP production process and quality procedures, including the preparation of quality documents such as CAPA, CC, SOP, and Memo; proficient in material management systems like SAP and MDG; 精通办公自动化软件MS-Office； Proficient in MS-Office office automation software; 如熟悉GMP文件管理系统MasterContro，质量事件追踪系统TrackWise为佳 Familiarity with GMP document management systems such as MasterControl and quality event tracking systems like TrackWise is highly recommended 有较强的跨组跨部门沟通协调能力，组织任务推动能力 Possesses strong cross-group and cross-departmental communication and coordination skills, as well as the ability to organize and drive task execution

1. 01

   负责生产任务的班次协调和排班 Responsible for shift coordination and scheduling of production tasks

2. 02

   负责车间物料暂存及接收、退库、投诉等管理，负责项目物料的调拨、需求整理、预警等，能够熟练使用SAP系统进行生产批次的物料管理 Responsible for the temporary storage, receipt, return, and complaint management of workshop materials, as well as the allocation, demand organization, and early warning of project materials. Proficient in using the SAP system for production batch material management

3. 03

   负责生产人员的资质管理和培训协调，GMP人员的资质更新、培训任务的安排和追踪，确保生产人员获取对应的资质 Responsible for the qualification management and training coordination of production personnel, as well as the qualification renewal, task arrangement, and tracking of GMP personnel, ensuring that production personnel obtain the corresponding qualifications

4. 04

   负责组内GMP文件的管控、流转、保存、归档、追踪记录 Responsible for the control, circulation, storage, archiving, and tracking records of GMP documents within the team

5. 05

   负责组内质量事件的追踪、记录（包括偏差、变更、审计发现项等） Responsible for tracking and documenting quality incidents within the team (including deviations, changes, audit findings, etc.)

6. 06

   负责定期向部门更新、汇报生产状况 Responsible for regularly updating and reporting production status to the department