Analytical Operations Specialist (1Y 8M, Replacement of maternity leave)
On-siteSeoul, Seoul, South Korea
Job Summary
Coordinate analytical method transfers between manufacturing sites and third-party laboratories, reviewing protocols, reports, and reagent logistics for Korea market compliance. Lead investigations into deviations and out-of-specification results, ensuring root causes and corrective actions are identified and closed. Manage quality systems, including GMP audits, regulatory inspections, and change control processes with external partners. Oversee reagent inventory, contract management, and pharmacopoeia intelligence to maintain continuous improvement in the Quality Management System. Support global teams with Quality Agreements and audit readiness while driving risk mitigation strategies.
Required Qualifications
- Bachelor's degree or equivalent / Science (Biology, Biochemistry, Microbiology, Biotechnology or Applied Chemistry)
- 3 years in QA/QC, QC experience
- Knowledge in quality and regulatory requirements (GSK QMS, Regulation, Policy)
- English proficiency (written and spoken)
- Data Integrity
- Detail-Oriented
- Digital Fluency
- GxP Regulations
- Pharmaceutical Regulatory Compliance
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing
Desired Qualifications
- Self-starter with continuous improvement mindset
- Strong in implementation with business mindset
- Enjoy challenge and problem solving
- Strong Team player, able to work collaboratively with colleagues and stakeholders (Teamwork)
- Excellent interpersonal and communication skills
- Influencing Without Authority
- Lean Management
- Problem Solving
- 3 years in QA/QC, QC experience is highly preferred
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