Quality Lead
On-siteSuzhou, Jiangsu, China
Job Summary
Maintain and continuously improve the Quality Management System to ensure compliance with GMP, GSP, corporate QMS, and all applicable regulatory requirements. Supervise key production processes, review batch records, ensure data integrity, and be responsible for product release. Manage NCR/CAPA activities by leading investigations, performing root cause analysis, and developing effective corrective and preventive actions with timely closure. Lead the change control process to ensure thorough impact assessment and verification prior to implementation. Optimize the company's quality system architecture for improvement and simplification. Perform team performance management, talent development, and foster an efficient, compliant, and collaborative quality culture. Complete other tasks assigned by management.
Required Qualifications
- Quality Management System maintenance and continuous improvement
- Compliance with GMP, GSP, corporate QMS, and all applicable regulatory requirements of targeted markets
- Supervision of key production processes
- Review of batch records
- Ensuring data integrity
- Responsibility for product release
- NCR/CAPA management
- Leading and guiding investigations
- Root cause analysis
- Development of effective CAPA
- Ensuring timely closure of CAPA
- Leading the change control process
- Ensuring thorough impact assessment prior to implementation
- Ensuring adequate verification and validation prior to implementation
- Ensuring CQAs and CPPs remain effectively controlled
- Optimization, improvement, and simplification of the company's quality system architecture
- Team performance management
- Talent development
- Building an efficient, compliant, and collaborative quality culture
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