KF BO - R&D Quality Officer

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

Founded in 1966, Kalbe Farma (Kalbe) is the largest publicly-listed pharmaceutical company in Southeast Asia. As of end 2023, Kalbe's extensive healthcare ecosystem encompasses a network of 47 companies, including subsidiaries, joint ventures, and associates, all driven by a dedicated workforce of 16,795 employees.

Guided by a vision to become the country's best global healthcare company, Kalbe offers a comprehensive healthcare solution through its four key business divisions: prescription pharmaceuticals, consumer health, nutrition, and distribution & logistics. Within these divisions, Kalbe manages a diverse portfolio reinforced by a robust distribution network that serves over one million outlets across Indonesia's vast archipelago.

On the international stage, Kalbe has established a strong presence in ASEAN countries, as well as regions spanning East and South Asia, the Middle East, and Africa. Kalbe's business ventures are supported by best in- class research and development capabilities, developed through strategic alliances with many international partners. The Company is deeply involved in cutting-edge areas such as drug delivery systems, cancer treatment, stem cell research, and biotechnology.

Job Description

• 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.

Company:

KF PT. Kalbe Farma Tbk.