1、Participate in equipment design confirmation, installation, commissioning and validation during plant interior construction, assist the dispensing supervisor, complete DQ, FAT, SAT, IQ, OQ and PQ of production equipment, mainly including cleaning machines, sterilization cabinets and dispensing systems, etc..

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

3、Assisting the dispensing supervisor to complete pilot batches, engineering batches, PPQ, media simulation tests, product process validation, cleaning validation and trial production. 

4、Complete the transfer of the product production process from R&D to production and organize the post for trial production; ensure the post achieves continuous and stable production operation  

5、Assisting the dispensing supervisor in solving technical problems and deviation investigations that occur during the dispensing and decontamination process.

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

1、Pharmaceutical, pharmacy, chemistry or related majors with college degree or above.

2、More than 1 year of experience in front-line production.

3、Familiar with weighing and dispensing regulations, moist heat sterilization, sterilization and filtration regulations.

4、Familiar with the design (especially BPE) and operation requirements of stainless steel dispensing system.

5、Familiar with the structure and principle of weighing hoods, stainless steel dispensing systems, appliance cleaners, moist heat sterilization cabinets, glue plugs/cleaners, VHP transfer windows, etc.

6、Have some awareness of aseptic risk.

7、Familiar with pharmaceutical production quality management norms and GMP site management and documentation.

8、Familiar with workshop validation and able to assist dispensing supervisor to complete process validation, cleaning validation and equipment validation in the workshop.