上海招聘

Quality Compliance & Training Senior Specialist

This position mainly focus on quality compliance, inspection related activities (such as client audit and on-site inspection preparation & support) and training activities. For these tasks, we do expect some experienced and mature persons (such as experienced Sr. Specialist) with good professional knowledge and interpersonal skills.

JOB DESCRIPTION

1. Following good documentation practice to build up and maintain good documents control system in quality control system.

2. Manage compliant report, adverse event report and field safety action, maintain the relative quality record.

3. Monitor / support the CAPA to be implemented in QC effectively.

4. Provide advice and training on compliance policies and regulations.

5. Coordinate with compliance specialists in rest of company.

6. Support the QC managers for training arrangement, including participants notice, training documents, training facilities and organize diversified training activities.

7. Analyze training data to optimize operation process and maintain learning management system.

8. Be the internal auditor to conduct internal QMS audit in QC organization.

PERSONAL QUALIFICATION

1. Bachelor’s degree or above defined as related Biopharma/Analytical field.

2. No less than 5 years’experience in the conduct of QC operations or quality management.

3. Excellent insight into GMP and QC lab operations.

4. Good written, oral communication, presentation, and computer skills.

5. Read, write, and speak fluent English.

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