Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Management of quality documentation (Quality Manual, Procedures, PMF, Local Language Label, etc)
- ISO 13485/MFDS/Corporate audit
- CAPA & Risk management
- Supplier management
- Quality release of repaired products
- Complaint handling and follow-up in Korea
- Assess the reportability of global complaints and report foreign adverse events to MFDS
- Field action including recall activity, quality hold, issue evaluation, etc
- PMS data collection for license renewal and reevaluation
- Maintenance of KGMP certificates, including on-site audits and document audits
- UDI registration and maintenance, and Monthly supply report
- Track and follow up on the new regulations/requirements
Qualifications
Highest qualification: University
- Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred
- Minimum of 3-4 years of experience required in Quality Assurance
- Certifications are an advantage, including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC