北京招聘

工作职责:

1. Conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary.

2. Conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc.

3. Promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable; Follow up implementation of CAPA, when applicable.

4. Assist inspections by client or regulatory agency when necessary.

5. Assist and advise QA management on quality system improvement.

6. Assist to schedule/conduct inspections of QA activities.

7. Support other quality systems out of BAS test facility when necessary.

8. Conduct work described in the related SOPs and according to OECD, FDA and CFDA, etc., GLP guidelines as well as other applicable regulations.

9. Work with QA management to lead the group to support the GLP, etc., program.

10. Work with QA management to develop strategic plan and execute the plan for the development of QA department.

11. Conduct the work delegated by QA management.

任职资格:

1. Have the ability to understand the basic concepts underlying the activities being monitored. Have a thorough understanding of the Principles of GLP.

2. Be familiar with the test procedures, standards and systems.

3. Be trained or have expertise and experience with the requirements of the OECD, FDA and CFDA, etc., GLP guidelines as well as other applicable regulations.

4. Be skillful at reading, understanding and writing English documentation.

5. Have good communication skills, both written and verbal, and work in a team-oriented manner.

6. Have good leadership and working experience in Quality management.

7. BS, MS or Ph.D. degree in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience.

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