Quality Assurance Specialist
Core
Ensure quality compliance of imported pharmaceutical products with Korea Pharmaceutical Law, Novartis Corporate Quality Manual, and cGxP requirements.
Role type
Quality Assurance Specialist (Pharmaceuticals)
Builds
Drug products released to market in compliance with registered specifications and regulations
Domain
Pharmaceuticals / Regulatory Compliance
Required skills
GMP Compliance, Regulatory Compliance, Change Control Management, Document Control, Complaint Management, Recall Management, CAPA Implementation, Adverse Event Reporting, Data Integrity, Audit Management
Preferred skills
Analytical Thinking, Project Management, Negotiation, Stakeholder Management
Technologies
GMP, cGxP, QMS
Responsibilities
Manage external inspections, complaints, deviations, recalls, and counterfeits; Manage technical complaints and investigation processes; Report and follow up spontaneous adverse events; Establish working relationships with Supply Chain and RA departments; Report and monitor Key Quality Indicators (KQIs).
