Job Description

Job Title:                     Quality Assurance

Industry:                      Pharmaceuticals

Location:                     China

Salary:                         Competitive Salary Package + Benefits

Qualification: Bachelor Degree or above in Pharmaceutical, Chemistry or related major

Responsibilities:                                                                                 

Document Control  

• Responsible for Document Control. Manage Quality Document effectively and timely to ensure availability of effective version of Documents. Archive Quality Documents and ensure traceability.

Change Control 

• Establish and maintenance Change Control System. Ensure effective evaluation of each change and follow change implement status. Archive all documents which are related with change.

CAPA

• Maintenance CAPA system. Follow up CAPA status. Ensure close CAPA in time.

Deviation Management  

• Maintenance Deviation handling system. Coordinate risk assessment for deviation and review corrective actions for deviation. Ensure close deviation in time. 

Vendor Quality Management 

• Maintenance Vendor file, vendor quality audit file, vendor quality agreement, etc. Finish yearly vender performance evaluation with Purchase team together. Define vendor quality audit plan.

Materials and finished product release   

• Release materials and finished product correctly and effectively. And maintenance database if necessary.

GMP Training GMP  

• Establish effective training system and define training plan and training need with stakeholder.

Record Control 

• Control record and ensure effective version for usage departments.

Internal Audit

• Define internal audit plan and organize internal audit. Ensure GMP compliance.

Any other tasks allocated by site management /organization.