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Roles & Responsibilities
- Establish quality master plan and implement quality management system in compliance with local regulations/guidelines and company procedures, including document management.
- Manage non-conformances, root cause investigations and propose corrective and preventive actions.
- Conduct Product Quality Review, where required.
- Responsible to manage change controls and coordinate annual management review.
- Manage local suppliers/vendors, including routine oversight of DC quality operations.
- Review documents and ensure the process and procedure are well documented and executed under data integrity.
- Provide necessary trainings to the office staff and staff of the distribution center to improve quality standards.
- Maintain all quality documentation such as product master file and standard operation procedures in accordance with local regulations and registered details.
- Review and approve artworks and labelling materials.
- Prepare and manage regulatory inspections by MFDS and regional audit by regional quality group.
Complaint Handling & Recall
A minimum of Bachelor’s degree in pharmacy, chemistry or biology is required.
Pharmacist license is required.
A minimum of 3 years of working experience in the quality affairs of pharmaceutical or medical device industry is required.