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Quality System Specialist/Supervisor
Suzhou , ChinaProcess Development

Principal Duties and Responsibilities

1. Implement and manage CMAB’s deviation, investigation and CAPA systems.

2. Manage CMAB’s Change Management System.

3. Responsible for the Client complaint and assist with product return, withdrawal or recall activities, as needed.

4. Responsible for the Risk Management.

5. Assist for implementing GMP training function for the Suzhou site

6. Organizing GMP training requirements and curricula.  Design and conduct, or outsource, training courses to enhance GMP knowledge level among company personnel.

7. Develop and execute training modules for new hires.

8. Responsible for internal auditing program.

9. Ensure that the internal audit list and schedule are maintained and executed as approved.

9. Organize CAPA response and follow up.

10. As facilitator, participate the client/authority audit and due diligence.

11. Organize response and follow up to any assigned observations.


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