GMP下游纯化及自动化开发

-MFG17 Job Responsibility-MFG17 1) 负责按GMP要求进行生产活动的执行，确保批生产活动符合当前GMP的要求。 Be responsible for GMP

. Make sure to complete batch production activities under GMP compliance.

2. 02

   协助完成项目的生产前准备工作包括文件、仪器及物料等进行及时的跟踪、总结和更新。 Coordinate the timely follow up, summary and update of the manufacturing preparation including documents, equipment and raw materials for projects assigned.

3. 03

   负责按GMP要求进行洁净区的清洁消毒工作，如现场清洁和设备表面清洁等。 Be responsible for cleaning in the clean area per GMP requirement, such as changeover cleaning and equipment cleaning, etc.

4. 04

   负责物料的下单、跟踪和管理等工作。 Be responsible for ordering, tracking and managing the raw materials.

5. 05

   协助设备的采购、验证、校验、维护和管理等工作。 Coordinate the ordering, validation, calibration, maintenance and management of the process equipment/instruments.

6. 06

   负责起草、升版、签批、分发、回收和归档GMP相关文件，包括但不限于SOP/MBR/URS/FAT/SAT/IOQ。 Be responsible for drafting, upgrading,receiving, distribution, recalling and archiving SOP/MBR/URS/FAT/SAT/IOQ or other GMP related documents.

7. 07

   参与偏差的启动和调查、变更的启动和实行、纠正和预防措施的执行。 Involving in the initiation and investigation of deviation, initiation and execution of change control, implementation of CAPAs.

8. 08

   按时完成个人的培训任务，配合对有需求的员工或其他部门进行相关培训。 Be responsible for training or coordinating training, and maintaining individual training record on time.

9. 09

   负责部门日常行政事务，完成上级交待的其他相关任务。 Be responsible for group or department administrative affairs. Perform the task assigned by leader.