Quality Operation Manager
1 week ago
Tugas dan Tanggung Jawab :
- Bertanggung jawab terhadap pengendalian dan pengawasan seluruh kegiatan Pengawasan Mutu dan Pemastian Mutu perusahaan, serta memastikan semua produk yang dihasilkan memenuhi syarat dan spesifikasi yang ditentukan
- Melakukan pengawasan pelaksanaan CPOTB, CPOB, dan Manual Sistem Management Mutu perusahaan
- Memastikan seluruh pengujian bahan baku, bahan kemas dan produk jadi selama proses produksi sesuai prosedur
- Memastikan pengelolaan vendor dilakukan sesuai prosedur, meliputi penilaian vendor dan audit terhadap vendor
- Memastikan pelaksanaan Rencana Induk Validasi, dan berkoordinasi untuk proses kalibrasi untuk seluruh system dan peralatan
- Memastikan penanganan product complaint, product recall dan evaluasi produk yang diterima dari pasar dilakukan sesuai prosedur
- Melakukan kajian dan pemeriksaan protap, protocol, laporan validasi, usulan perubahan proses, bahan dan metode pemeriksaan
- Memastikan ketersediaan alat-alat / reagent yang dibutuhkan untuk Analisa
- Memastikan pelaksanaan uji stabilitas on-going terlaksana, termonitor dan terevaluasi
- Membuat anggaran tahunan dan monitoring realisasi penggunaan anggaran
Spesifikasi Posisi :
- Pendidikan Minimal Apoteker
- Pengalaman: Minimal 8 tahun di bidang Quality, dengan 3 tahun sebagai Quality Manager, khususnya dalam Pengawasan Mutu, Pemastian Mutu, atau Pengembangan Produk Farmasi, terutama Obat Tradisional,
- Memiliki pengetahuan CPOB, CPOTB, PMP, Sistem Jaminan Halal dan Regulasi di bidang Obat Tradisional dan Farmasi
- Bertanggung jawab (hands-on terhadap tugas) dan memiliki kemampuan kepemimpinan yang baik terkait kemampuan pengambilan keputusan, mencari solusi yang terbaik dan mampu mengarahkan/mengembangkan tim dengan baik
- Memiliki kemampuan Analisa & inisiatif yang baik, serta komunikasi dan interpersonal skill yang baik
- Penempatan di Cikarang
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