P
PT Erela
Qualification & Validation QC Supervisor
Skills
Testing & QA
2 months ago
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Important information
Contract type:
Permanent
Location:
Semarang, Semarang City, Central Java, Indonesia
Work mode:
Onsite
Published on:
29 August 2026
What they need
Jobdesc
- Memastikan seluruh kegiatan qualification & validation (equipment, utility, metode analisa) berjalan sesuai standar CPOB.
- Menyusun, mereview, dan menyetujui dokumen protocol, report terkait validation & qualification.
- Mengkoordinasikan pelaksanaan IQ, OQ, PQ serta method validation/ verification di laboratorium QC.
- Melakukan evaluasi data hasil validasi untuk memastikan keakuratan dan kepatuhan terhadap regulasi.
- Berkolaborasi dengan tim QA, Produksi dan pihak terkait dalam kegiatan validasi.
Kualifikasi
- Pendidikan minimal S1 Farmasi / Profesi Apoteker, memahami standar CPOB, CPOTB dan regulasi BPOM
- Memiliki pengalaman minimal 3 tahun di bidang QC Validation / Qualification pada industri farmasi
- Menguasai konsep: Equipment Qualification (IQ, OQ, PQ); Method Validation / Verification; Cleaning Validation ; Computerized System Validation.
- Penempatan Semarang
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