Asisten Manajer Quality Assurance

4 days ago

Semarang, Central Java, Indonesia PT Sampharindo Retroviral Indonesia - Semarang Full time 3,000,000 - 6,000,000 per year

Keterampilan, kualifikasi, dan pengalaman yang dibutuhkan :

  • Memiliki gelar Apoteker
  • Memiliki pengalaman kerja minimal 5 tahun di bidang Quality Assurance, terutama industri manufaktur farmasi.
  • Memiliki keterampilan dalam mengawasi dan memastikan penerapan CPOB (Cara Pembuatan Obat yang Baik) di seluruh lini produksi
  • Memiliki pengalaman memimpin kegiatan sistem mutu seperti penanganan deviasi, CAPA, change control, dan audit internal.
  • Memiliki pemahaman yang kuat tentang peraturan dan standar kualitas yang berlaku di industri farmasi.
  • Kemampuan analitis yang kuat, dengan keterampilan pemecahan masalah yang baik
  • Komunikasi yang efektif, baik lisan maupun tertulis, dalam bahasa indonesia dan bahasa inggris.

Tanggung jawab :

  • Merancang, mengimplementasikan, dan memantau program penjaminan mutu yang efektif untuk memastikan kepatuhan terhadap standar mutu dan regulasi yang ditetapkan.
  • Mengembangkan dan menerapkan kebijakan dan prosedur jaminan mutu.
  • Memastikan kepatuhan terhadap GMP dan memastikan sistem mutu diterapkan sesuai dengan peraturan terbaru.
  • Memastikan pemenuhan persyaratan teknis GMP atau peraturan BPOM terkait mutu produk jadi.
  • Memimpin, mengevaluasi dan mendokumentasikan penanganan investigasi masalah penyimpangan dan pengendalian perubahan, dan mengimplementasikan tindakan korektif dan preventif yang tepat.
  • Mengevaluasi produk jadi untuk dijual dengan mempertimbangkan semua faktor terkait.
  • Melakukan penilaian mutu produk dalam program penilaian mutu produk tahunan.
  • Berkoordinasi dengan tim produksi untuk memastikan proses dan prosedur yang efisien dan konsisten.
  • Memantau dan menganalisis indikator kinerja utama (KPI) untuk memastikan pencapaian target mutu.

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