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Regulatory Ski And License Manager
Company | PT Tempo Scan Pacific Tbk |
Address | Jakarta, Indonesia |
Employment type | FULL_TIME |
Salary | |
Category | Manufaktur Produk Perawatan Diri,Manufaktur,Manufaktur Farmasi |
Expires | 2024-02-25 |
Posted at | 8 months ago |
Tugas dan Tanggung Jawab :
- Memastikan dokumentasi berkas dengan mengupdate digital library yang dibutuhkan untuk pengurusan SKI
- Bertanggung jawab memastikan seluruh registrasi SKI dan Perijinan di Tempo Scan Group dapat terlaksana sesuai target yang ditetapkan.
- Bertanggung jawab atas penyusunan self assessment dan verifikasi kelengkapan data/dokumen/sampel untuk registrasi SKI
- Memonitor dan memastikan proses perijinan dan sertifikasi pabrik farmasi, pabrik obat tradisional, pabrik kosmetik & PKRT, alkes dan distribusi/PKS berjalan baik dan tepat waktu
- Menjaga hubungan baik dengan pihak eksternal seperti BPOM, Kemenkes, Dinkes dan melakukan follow up terkait penyelesaian perijinan / sertifikasi
- Secara berkala melakukan update informasi/regulasi yang berkaitan dan berdampak kepada perijinan Tempo Scan Group.
Kualifikasi :
- Memiliki inisiatif dan kemampuan bekerjasama yang baik
- Memahami kemampuan project management dan time management yang baik
- Memiliki kemampuan komunikasi dan interpersonal skill yang baik
- Memiliki pengalaman minimal 5 tahun menangani regulatory di perusahaan obat / fmcg / kosmetik
- Pendidikan Minimal S1 Farmasi, Apoteker ataupun Teknik Kimia dengan IPK min 3.00
- Mampu mengambil keputusan / mencari solusi yang berkaitan dengan proses sertifikasi
- Memahami regulasi terkait GMP
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