Healthcare Quality & Regulatory Compliance, Senior Specialist

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