质量管理主管/经理

工作地点：无锡         所属类型：GCS-Formulation         发布时间：2022-03-22

岗位描述：

1. Act as auditor in quality management department of BioDuro Wuxi region.

2. Act as file coordinator of Quality Management department to manage all related files including archiving.

3. Participate in development of quality-related processes and SOP.

4. Provide internal QM audit and inspection support as directed. This may include: providing assistance/advice for audit/inspection preparation; representing Quality Management in audits and inspections as required.

5. Provide support for management of quality issues. Facilitate and advise on corrections and corrective actions related to designated quality issues. Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program.

6. Provide Quality direction and training to new and existing employee and provide QM consultant for different businesses of BioDuro.

7. According to company strategy and client’s requests, coordinate related departments of BioDuro China region to execute QM systems of GXP, ISO, etc.

8. Collaborate with related departments to pass external audits and track the CAPA to close.

9. Perform Quality Lead-related tasks assigned.

任职资格：

1. Bachelor’s degree or above (chemistry, biological science, pharmacy or other health related discipline preferred)

2. More than 5 years pharmaceutical quality management related experience

3. Familiar with pharmaceutical quality management standards, ex. GXP, ISO, etc.

4. Good oral & written English.

5. Ability to work independently, takes initiative, and has a flexible approach with respect to work assignments and new learning.

6. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.