KF BO - R&D Quality Officer

KF PT. Kalbe Farma Tbk.; Bekasi; Vor Ort; IDR 240.000.000 - 420.000.000; Vollzeit

Zusammenfassung

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.

Aufgaben

• 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.

Kenntnisse

CAPA management

Change Control

Document management

Audits support

Calibration & CSV

Jobbeschreibung

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.