质量保证经理/Quality Assurance Manager, GMP

2021-01-12

Position: Quality Assurance Manager, GMP


Report to: CMC


Location: Shanghai


DUTIES & RESPONSIBILITIES 

1.     Develop, monitor, and implement quality management procedures and policies according to quality standards to ensure products satisfy the expectation.

2.     Diligently assess the effectiveness and efficiency of internal controls in daily processes as well as compliance with national laws and corporate guidelines. 

3.     Continuously improve the Quality Management System.

4.     Maintenance of quality management system

5.     Create and maintain related procedures of quality system.

6.     Create and review quality related documents

7.     Train the new employees of quality documents.

8.     Support maintenance and improvement of training management process.

9.     Responsible for supplier management:

10.   Revise and maintain change control SOP.

11.   Register the change control. Maintain the change control log. Organize the evaluation of change. Follow up the change control.

12.   Responsible for internal audit

13.   Revise and maintain internal audit SOP.

14.   Draft internal audit plan.

15.   Execute internal audit per audit plan. Participate in internal audit.

16.   Draft internal audit protocol and report.

17.   Follow up internal audit and corrective actions.

18.   Participate investigation of deviation/non-conformance and determination of CAPA plan.

 

KNOWLEDGE AND COMPETENCIES 

1.     Minimum BS, in Life sciences, biology, chemistry, engineering, pharmacy, or similar scientific discipline.

2.     Minimum of 10 years of QA/QC/MFG experience in the pharmaceutical industry and/or QA/QC/MFG environment. Experience of cGMPs/GMPs, ICH and other pertinent regulations.

3.     Attention to details with an ability to perform critical review of various types of documents.

4.     Ability to independently solve problems and work cross-culturally.

5. Fluent Chineses and English both in spoken and written.



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