1、Participate in equipment design confirmation, installation, commissioning and validation during plant interior construction, assist filling supervisor, complete DQ, FAT, SAT, IQ, OQ and PQ of production equipment, mainly including automatic filling and corking machines, VHP transfer windows and VHP equipment, etc.

2、Assist the filling supervisor to complete the development of production related documentation system within GMP system, filling process related protocols, risk assessment, job operation SOPs and production equipment operation SOPs. 

3、Assisting the filling supervisor in completing pilot batches, engineering batches, PPQ, media simulation tests, product process validation, cleaning validation and trial production. 

4、Completing the transfer of the product production process from R&D to production and organizing the post for trial production; ensuring that the post achieves continuous and stable production operation;.

5、Assisting the filling supervisor in solving technical problems and deviation investigations occurring during the filling and decontamination process. 

6、Responsible for the daily production operation of filling of aseptic preparation products, filling of post production related records, cleaning and maintenance of filling equipment and environment. 

1、Biology, pharmacy, pharmaceutical and related majors, college degree or above. 

2、1 year and above working experience in filling position, proficient in operating filling equipment, GMP certification experience is preferred. 

3、GMP related professional knowledge background and aseptic operation concept and operation experience. 

4、Good sense of responsibility, strong anti-stress ability, extremely strong teamwork spirit, and good communication skills.

5、Familiar with pharmaceutical manufacturing quality management norms and GMP site management and documentation.

6、Familiar with workshop validation, able to assist the filling supervisor to complete the process validation, cleaning validation, equipment validation, etc. in the workshop.