QA Manager (Licensed Pharmacist)
alcon · Seoul
Job description
About the role
Alcon, a global leader in eye care, is seeking a QA Manager who will act as the Responsible Pharmacist for imported pharmaceuticals in Korea. The role ensures compliance with Korean regulations and global quality standards while providing strategic leadership across product quality, batch release, and supplier oversight.
Key responsibilities
- Serve as the Responsible Pharmacist for imported pharmaceutical and medical device products.
- Oversee deviations, investigations, CAPAs, change controls, risk assessments, supplier quality events, and complaints.
- Own batch disposition, import testing, and final release, including review and approval of test results.
- Lead preparation and management of government inspections, corporate audits, and third‑party audits.
- Manage recalls, field safety corrective actions, and quality‑related regulatory reporting.
Required profile
- B.A. degree in Pharmaceuticals or related healthcare science.
- Licensed Pharmacist.
- Fluent in English.
- Minimum 10 years of relevant experience in the medical device and/or pharmaceutical industry.
Required skills
- In‑depth knowledge of MFDS regulations, GMP, GDP, and related quality standards.
- Experience with batch release, import testing, and final product release processes.
- Proficiency in managing investigations, CAPAs, change controls, and risk assessments.
- Ability to lead audits, inspections, and supplier qualification activities.
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alcon
Seoul