KF BO - R&D Quality Officer

Kalbe-Farma; Bekasi; Sur place; IDR 180 000 000 - 300 000 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

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

Description du poste

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.