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

Kalbe-Farma; Bekasi; On-site; IDR 180,000,000 - 300,000,000; Full time

Job summary

Kalbe Farma is seeking a qualified professional to oversee deviation monitoring and CAPA processes within its quality system in Indonesia. The role includes change control, ensuring robust document management, archiving, backup/recovery, and ongoing process audits, with CAPA reporting and external audit support in collaboration with QA and Engineering teams.

The position also covers qualification and calibration activities, including CSV for new and existing instruments, working with LMM, QA and

Qualifications

• Registered professional with experience in deviation handling.
• Experience implementing CAPA, Change Control, and document management.
• Familiarity with CSV and calibration of lab instruments.

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.

Skills

CAPA management

Change Control

Document management

Archiving

Backup & Restore

Process auditing

CAPA reporting

External audit support

Qualification & calibration

CSV for instruments

Collaboration with QA/Engineering

Job description

Kalbe Farma is seeking a qualified professional to oversee deviation monitoring and CAPA processes within its quality system in Indonesia. The role includes change control, ensuring robust document management, archiving, backup/recovery, and ongoing process audits, with CAPA reporting and external audit support in collaboration with QA and Engineering teams.

The position also covers qualification and calibration activities, including CSV for new and existing instruments, working with LMM, QA and