KF BO - R&D Quality 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

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. 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.