Production Drug Substance (DS) Specialist
SKPlasma Core Indonesia · KARAWANG, JAWA BARAT, ID
Sekilas tentang pekerjaan ini
Di SKPlasma Core Indonesia, Production Drug Substance (DS) Specialist menjalankan dan mendukung manufaktur Drug Substance yang memenuhi GMP di Karawang, Jawa Barat. Posisi level Specialist juga berkoordinasi lintas fungsi untuk mendukung kelancaran operasi dan mutu produk.
Tugas utama
- Menjalankan dan mendukung manufaktur Drug Substance sesuai SOP dan GMP.
- Memantau peralatan produksi DS dalam parameter tervalidasi.
- Memeriksa kelengkapan, keakuratan, dan kepatuhan GMP dokumentasi produksi.
- Mendukung pengendalian proses dan pemantauan selama manufaktur DS.
- Mendukung investigasi deviasi, analisis akar masalah, dan penerapan CAPA.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs SKPlasma Core Indonesia.
Deskripsi pekerjaan
Role Purpose
To execute and support Drug Substance manufacturing operations by ensuring GMP‑compliant production processes, documentation accuracy, and coordination across functions to deliver consistent, high‑quality drug substance.
Role Description (Detail & Level‑Appropriate – Specialist)
- Execute and technically support Drug Substance manufacturing processes (upstream and downstream) in accordance with approved SOPs, batch records, and GMP requirements.
- Support operation and monitoring of DS production equipment (e.g. bioreactor, chromatography systems, UF/DF, process tanks) within validated parameters.
- Review and verify batch records, logbooks, and production documentation for completeness, accuracy, and GMP compliance before submission.
- Support process control, in‑process monitoring, and deviation identification during DS manufacturing activities.
- Participate in and support process validation, scale‑up, and technology transfer activities for Drug Substance processes.
- Support deviation investigation, root cause analysis, and CAPA implementation related to DS manufacturing.
- Coordinate with QA, QC, Engineering, and Production Planning to ensure smooth execution of DS operations.
- Support change control implementation related to DS processes, equipment, or materials.
- Support audit and inspection readiness for DS manufacturing areas by ensuring documentation and process compliance.
- Act as technical reference for DS Operators, providing guidance during routine operations and troubleshooting.
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