R&D Quality & Compliance Officer

Kalbe Group; Bekasi; On-site; IDR 150,000,000 - 350,000,000; Full time

Job summary

Kalbe Farma is seeking a QA professional to join its quality and compliance team in Indonesia. The role focuses on registering, monitoring, and controlling deviations (DR/OOX), implementing CAPA, and managing change control processes across procedures and instruments.

The position includes establishing and maintaining a robust document management system, archiving, backups, and ongoing process audits in collaboration with QA, LMM and Engineering teams.

Responsibilities

• Registered, monitoring & Control Deviation (DR, OOX)
• Implement CAPA management
• Implement Change Control Management
• Implement document management system, including, blank form control , Archiving & Retrieve, Backup & restore
• Periodic process Audit, reporting & managing CAPA.
• Support external Audit
• Qualification & calibration & CSV for new and existing instruments collaborate wuth LMM, QA and Enggineering.

Job description

Kalbe Farma is seeking a QA professional to join its quality and compliance team in Indonesia. The role focuses on registering, monitoring, and controlling deviations (DR/OOX), implementing CAPA, and managing change control processes across procedures and instruments.

The position includes establishing and maintaining a robust document management system, archiving, backups, and ongoing process audits in collaboration with QA, LMM and Engineering teams.