Healthcare Quality & Regulatory Compliance, Senior Specialist
Flintex Consulting
20 days ago
Full-time
On-site
Seoul, Seoul, South Korea
Auditing, Regulatory, Quality, and Compliance
1. Regulatory & Quality Compliance
⢠Ensure compliance with Korean healthcare / pharmaceutical regulations ( Eg KGSP)
⢠Approve incoming / released/returned products through specification and visual checks
⢠Maintain and update key quality documents ( Quality Manual, SOP, WI)
⢠Conduct internal audits and oversee environmental hygiene
⢠Interpret regulatory standards and ensure process compliance
2. Training Management
Develop and deliver regulatory / quality training programs for employees
3. Quality Issue Management
⢠Report and manage suspected counterfeit or adulterated products
⢠Investigate and improve QMS issues ( Change Control, Deviation, CAPA)
⢠Record and monitor quality issues to prevent recurrence
Job Requirements / qualifications
⢠Knowledge and practical experience related to the medicines Act
⢠Experience with ISO integrated management systems
⢠Internal audit and quality system enhancement experience
⢠Experience in delivery / transportation service quality management
⢠Practical understanding of KGSP and regulatory standards
⢠QMS operation and quality documentation management skills
⢠Audit and problem solving capabilities ( including CAPA /SOP optimisation )
⢠Training design and delivery skills
⢠Strong cross functional communication and collaboration
⢠Fluent or intermediate level in Korean and English as the role required to communicate with overseas counter part and reporting to overseas manager
⢠Possess valid local Pharmacist License
Working hours:
Mon to Fri 9am-6pm