QA Specialist

About the role

Alcon, a global leader in eye care, is seeking a QA Specialist to support its Quality Management System in the Republic of Korea. The role ensures compliance with GxP, quality regulations, and internal standards across product handling, supplier qualification, and audit activities.

Key responsibilities

• Maintain and improve the Quality Management System, covering GxP, self‑inspections, supplier qualifications, CAPA, and SOP compliance.
• Oversee receipt, inspection, storage, handling, release, distribution, transport, and destruction of incoming products according to regulatory and GxP requirements.
• Implement Alcon Quality System Procedures locally and ensure appropriate SOPs, work instructions, and training are in place.
• Manage document control, change controls, and local deviations, driving root‑cause investigations and corrective actions.
• Qualify and monitor GxP suppliers, conduct internal and supplier audits, and support external audits by notified bodies and health authorities.
• Handle complaints, recalls, counterfeits, and product tampering in line with corporate quality manuals.
• Collect and report key quality indicators and stay current with local and international regulatory trends.

Required profile

• University degree in a scientific or engineering discipline or equivalent.
• Fluency in written and spoken Korean and English.
• Minimum 2 years of experience in a quality role within the medical device or pharmaceutical industry.

Required skills

• Knowledge of GxP regulations and quality standards.
• Experience with CAPA processes, change control, and audit management.
• Proficiency in implementing and maintaining Quality Management Systems (QMS) and related SOPs.