Your challenge

The Quality System Manager is responsible for overseeing the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on managing the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.

• Electronic Quality Document System (eQMS) Management:

o Oversee the implementation, maintenance, and continuous improvement of the eQMS to ensure regulatory compliance.

o Manage document control, including the review, approval, and maintenance of SOPs and controlled documents.

o Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.

• Corrective and Preventive Actions (CAPA):

o Oversee the CAPA process, ensuring thorough investigation, root cause analysis, and timely...