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Open nowPosted 25 days ago

Quality Control Officer

Dexa Group104 open roles

Where
Palembang, Sumatera Selatan, Indonesia
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Your applicationOpen nowQuality Control OfficerDexa Group · Palembang, Sumatera Selatan, Indonesia
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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. Dexa Group postings stay open a median of 5 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 25 days ago

Dexa Group median: 5 days open

The posting

Job Description

Melakukan pengawasan, implementasi dan evaluasi kerja terkait kegiatan pengujian laboratorium baik pengujian mikrobiologi maupun fisika untuk bahan awal (starting material), selama proses pengembangan dan proses produksi, program preventive maintenance untuk instrument laboratorium sesuai prosedur standar dan spesifikasi yang ditetapkan untuk memastikan bahwa produksi obat memenuhi seluruh ketentuan CPOB/CPOTB, GLP, SOP, Standar K3L, HAS, serta Standar/Peraturan terkait lainnya.

Responsibilities

1. Menyusun perencanaan/target tahunan dalam bentuk Balance Score Card (BSC) individu dan timnya, mengusulkan rencana anggaran biaya kepada Atasan dan melakukan monitoring terhadap pencapaian/realisasinya.

2. Membuat dan menetapkan program kerja : - pengujian mutu untuk masing-masing Laboratorium Kimia-Fisika dan Laboratorium Mikrobiologi - pemeriksaan kemasan primer

3. Memastikan, memonitor, mereview, dan mengendalikan pelaksanaan :

  • pengujian kualitas bahan awal, produk antara/jadi sesuai spesifikasi dan juga aktivitas pengujian laboratorium kimia-fisika mikrobiologi untuk memastikan mutu sesuai prosedur / standar Farmakope/ Compendial/CPOB yang telah ditetapkan
  • pengadaan, penyimpanan dan pemantauan terhadap sampel pertinggal (retained sample)
  • pengujian selama validasi media fill yang dilakukan bersama team Quality dan Produksi
  • Analysis Methode Transfer
  • identifikasi dan pengendalian aspek dan bahaya terhadap K3 serta lingkungan di laboratorium QC
  • hasil uji diluar spesifikasi (HUDS) bersama-sama Bagian Produksi dan atau Quality
  • implementasi program CIP atau project yang sudah ditetapkan
  • change control bersama Bagian lain yang terkait
  • audit internal dan eksternal.

4. Memastikan implementasi prosedur-prosedur pengujian dan pengawasan mutu di laboratorium Quality Control.

5. Me-review dan membuat pembaharuan sistem dan prosedur-prosedur di Bagian QC sesuai dengan tuntutan GLP dan GMP terkini maupun standard lain yang relevan (ISO, OHSAS, K3L, HAS) dalam rangka continuous improvement.

6. Memberikan instruksi, memantau (monitor) aktivitas kerja, dan mengembangkan anggota tim di bawah tanggung jawabnya sesuai dengan ekspektasi dan aturan yang telah ditetapkan.

Qualifications

  • Lulusan Profesi Apoteker
  • Bersedia penempatan di Palembang
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