Quality Assurance & Compliance Specialist (CAPA, Change Control)

Kalbe Farma; Bekasi; On-site; IDR 89,280,000 - 133,920,000; Full time

Job summary

Kalbe Farma in Bekasi, Indonesia is seeking a QA role focused on deviation monitoring, CAPA and change control within its regulated environment. The role involves coordinating with LMM, QA, and Engineering to ensure instrument qualification, calibration, and CSV compliance across new and existing devices.

The successful candidate will implement document management systems, perform periodic process audits, support external audits, and help maintain robust QC and compliance across Kalbe's

Qualifications

• Registered professional with experience in deviation monitoring and control (DR, OOX).
• Experience with CAPA management and Change Control procedures.
• Familiar with document management systems and archiving.
• Ability to perform periodic process audits and CAPA reporting.
• Support external audits and calibration/CSV for instruments.

Responsibilities

• Register, monitor & control deviations (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 with LMM, QA and Engineering.

Job description

Kalbe Farma in Bekasi, Indonesia is seeking a QA role focused on deviation monitoring, CAPA and change control within its regulated environment. The role involves coordinating with LMM, QA, and Engineering to ensure instrument qualification, calibration, and CSV compliance across new and existing devices.

The successful candidate will implement document management systems, perform periodic process audits, support external audits, and help maintain robust QC and compliance across Kalbe's