QA Specialist

Minimum qualifications:

A master's degree

Hiring:

1

Experience requirements:

1 - 3 years

Working area:

Shanghai Fengxian


Job Responsibilities:

 

1. Keep a copy of the research protocol for each study for which they are responsible, as well as a copy of the SOP of the experimental institution;

 

2. Perform relevant inspections for each GLP study responsible: protocol (change) review, experimental phase review, and report review;

3. Responsible for maintaining and updating the master schedule, and performing on-site inspections;

4. Timely report the inspection results to relevant personnel such as the person in charge of the subject, the person in charge of the institution, the person in charge of the facility, and so on;

5. Prepare a quality assurance statement for the subject for which they are responsible;

6. Develop relevant SOP for QA department;

7. Review other laboratory SOPs and provide regulatory recommendations;

8. Timely archive the data of the quality assurance department;

9. Other temporary work arranged by the manager of the quality assurance department.

 

Job Requirements:

1. College degree or above in medicine or animal medicine, with relevant experience in contract research organization (CRO) work;

2. Have good communication and coordination skills; Strong ability to analyze and solve problems, strong self-learning ability;

3. Familiar with the use of office software, with the ability to read and write English;

4. Be familiar with domestic and foreign GLP specifications, and understand the normal operation process of animal laboratories;

5. Good awareness of regulatory compliance.