About the job
Core
Ensuring GMP compliance and data integrity for manufacturing equipment, facilities, and water systems through validation, qualification, and quality management.
Role type
Senior Quality Assurance Engineer (GMP/Validation)
Builds
GMP-compliant manufacturing processes and equipment for SK Chemicals
Domain
Chemical manufacturing / Pharmaceutical-grade production
Required skills
GMP compliance, Validation (PV/CV/CSV), Qualification (BHT), QMS operation, Data Integrity management, OOS/OOT handling, CAPA management, Change control, Audit/Inspection response
Preferred skills
AI tool utilization, English fluency
Technologies
GMP systems, QMS platforms, Validation software
Responsibilities
Conduct validation and qualification (PV, CV, CSV, BHT) for equipment, facilities, and manufacturing water; Manage GMP compliance including CTD documentation and audit/inspection responses; Operate and improve QMS for deviations, OOS/OOT, changes, CAPA, and complaints; Manage Data Integrity including CS operations, access control, backups, recovery, and periodic reviews
