R&D Quality Lead: CAPA, Change Control & Audits

KF PT. Kalbe Farma Tbk.; Bekasi; On-site; IDR 240,000,000 - 420,000,000; Full time

Job summary

Kalbe Farma Tbk. is seeking a qualified professional to oversee quality systems, CAPA processes, and change control within its pharmaceutical operations in Indonesia.

The role focuses on deviation handling, document management, and audit support, ensuring compliance across the manufacturing spectrum. Key responsibilities include monitoring DR/OOX deviations, implementing CAPA and change control, and coordinating calibration/CSV for instruments in collaboration with QA and Engineering.

Responsibilities

• Register, monitor, and control deviation (DR, OOX).
• Implement CAPA management.
• Implement Change Control Management.
• Implement document management system including archiving & retrieval.
• Periodic process audits, reporting & managing CAPA; support external audits; calibration & CSV for instruments with QA and Eng.

Skills

CAPA management

Change Control

Document management

Audits support

Calibration & CSV

Job description

Kalbe Farma Tbk. is seeking a qualified professional to oversee quality systems, CAPA processes, and change control within its pharmaceutical operations in Indonesia.

The role focuses on deviation handling, document management, and audit support, ensuring compliance across the manufacturing spectrum. Key responsibilities include monitoring DR/OOX deviations, implementing CAPA and change control, and coordinating calibration/CSV for instruments in collaboration with QA and Engineering.