Location
kulim
Job Type
Full-time
Posted
June 07, 2026
Job Description
Summary
Assuring the conformance of organization’s regulatory and Quality Management System (QMS). Responsible for RA, labeling compliance, and project management, ensuring all requirements are met and projects are executed effectively.
Job Responsibilities
- Ensuring compliance with applicable regulatory requirements and maintain the effectiveness of the Quality Management System (QMS).
- Plan, coordinate, and execute internal and external audits, including supplier audits, and ensure timely closure of audit findings.
- Manage non-conformance processes, including investigation, root cause analysis, and implementation of corrective and preventive actions (CAPA).
- Oversee document control activities to ensure proper creation, review, approval, and revision of quality documents in compliance with standards.
- Support regulatory submissions, product registrations, and ensure adherence to applicable standards.