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.
- Monitor and analyze quality performance metrics, identifying trends and driving continuous improvement initiatives.
- Collaborate with cross-functional teams to ensure manufacturing processes and products meet quality and regulatory requirements.
- Perform any other related duties as assigned by immediate superior.
Qualifications
- Minimum Bachelor's Degree in Science or Engineering (or any relevant discipline)
- Minimum 1 year experience in manufacturing. Fresh graduates with responsible attitude are encouraged to apply.
- Effective communication skills and proficiency in Japanese language is an advantage.
- Proficiency in documentation tools and quality engineering report.
- Proficiency in English and Bahasa Malaysia are must, others will be an added advantage.
