KF BO - R&D Quality Officer
Kalbe Farma · Bekasi HO
Sekilas tentang pekerjaan ini
R&D Quality Officer di Kalbe Farma bertugas mengelola Deviation, CAPA, Change Control, dokumentasi, audit, serta kualifikasi dan kalibrasi instrumen. Posisi ini berlokasi di Bekasi HO.
Tugas utama
- Mendaftarkan, memantau, dan mengendalikan Deviation (DR, OOX).
- Menerapkan manajemen CAPA dan Change Control.
- Mengelola dokumen, termasuk kontrol formulir, pengarsipan, pemulihan, dan backup.
- Melakukan audit proses berkala, pelaporan, dan pengelolaan CAPA.
- Mendukung audit eksternal serta kualifikasi, kalibrasi, dan CSV instrumen.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs Kalbe Farma.
Deskripsi pekerjaan
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.