1、Responsible for drafting, revising and reviewing management and operational documents related to analytical instruments in the laboratory, and regularly checking and reviewing them to ensure that they are suitable for use.

2、Be responsible for the management of analytical instruments at the laboratory site and coordinate the use of instruments in the inspection group.

3、Develop or assist in the development of annual plans for laboratory instrument maintenance, metrology, confirmation/validation, etc., and implement them in accordance with the plans to ensure proper use of the instruments.

4、Participate in deviations, changes, etc. related to analytical instruments.

5、Coordinating the testing group's requirements for the use of analytical instruments and drafting or assisting in drafting the corresponding URS.

6、Participating in the development of the classification, authority, and strategy of the analytical instruments and their software in the laboratory.

7、Participate in the validation/validation implementation of analytical instruments and their software, draft or assist in drafting the corresponding validation/validation schemes and reports, including instrument validation, CSV, etc.

8、Responsible for communication with analytical instrument suppliers and coordination of instrument procurement, acceptance, installation, maintenance and replacement/obsolescence.

9、Responsible for the management of consumables for analytical instruments in the laboratory.

10、Maintaining laboratory layout and facilities, reporting and arranging for their abnormalities to be handled in a timely manner.

11、Participating in company self-inspection and official audits and answering questions related to analytical instruments.

12、Compile all types of incidents occurring in the laboratory analytical instrumentation and make regular reviews and assessments and reports.

13、Participate in cross-departmental communication with QA validation group, equipment engineering department and IT.

14、Complete other tasks assigned by the supervisor.

1、College degree or above in chemistry, biology, pharmacy or other related majors.

2、Master the basic principles of testing experiments; familiar with drug GMP regulations; familiar with the operation of QC instruments and equipment; familiar with the requirements of domestic and international regulations for computerized systems.

3、Good English reading ability and proficient in operating and using computers.

4、2 years or more working experience in pharmaceutical companies and more than 1 year of management experience.