Apoteker/Regulatory Officer (Alat Kesehatan & PKRT)

Hiring Company Description :

• Company Name: PT Keindahan Sejahtera Hutama

• Industry Type: Beauty

• Introduction: PT Keindahan Sejahtera Hutama is a company engaged in the distribution of beauty products from South Korea since its establishment in 2019. PT KSH also partnered with K-Style Hub (a Korean-based startup) to import, distribute, and market Korean beauty brands to Indonesian consumers. Until this day, PT KSH has successfully collaborated with various brands with advanced marketing strategy through "Unnis Pick", and expanded its business to develop beauty application "UNNIS".

• Term of Contract: contract

• Working Hours: 5 days per week, 8 hours per day

• Working location: BSD, Tangerang

Job Description:

• Mendaftarkan produk Alat Kesehatan & PKRT

• Bertanggung jawab pada perizinan impor Alkes dan tata cara distribusinya di Indonesia

• Melakukan pengecekan pada dokumen yang dibutuhkan (COA, MSDS, Formulasi, dll) sebelum, saat, dan sesudah produk didaftarkan, sesuai dengan peraturan yang berlaku

• Menyusun, mengimplementasikan, dan mengevaluasi prosedur penanganan produk sesuai dengan CDAKB & CAPA yang berlaku

• Bertindak sebagai PIC utama dalam pendampingan audit, inspeksi, dan sidak rutin dari BPOM/Kementerian Kesehatan (dan instansi lain yang berhubungan) serta memastikan kesiapan dokumen dan sistem

• Preparing halal certification documents for imported products

Requirements:

• Pendidikan minimal S1 Farmasi dan Profesi Apoteker (STR aktif, dan dapat mengurus SIPA)

• Pengalaman min. 1 tahun sebagai Regulatory Officer/PJT di bidang Alat Kesehatan & PKRT

• Pengalaman bekerja pada perusahaan distribusi Alat Kesehatan & PKRT adalah nilai tambah

• Good understanding of how PKRT, Medical Device/Alkes and Halal registration flow

Nice to Have:

• Sertifikat IDAK (Izin Distribusi Alat Kesehatan)

• Sertifikat CDAKB (Cara Distribusi Alat Kesehatan yang Baik)

• Sertifikat Pelatihan Alat Kesehatan / BMHP

Other Information:

• KOTRA Jakarta does not have the authority to decide on all matters relating to the interview, recruitment, and placement of workers that occur between The Hiring Company and Applicants. 

• The Hiring Company as mentioned above will contact applicants directly for the interview, recruitment, and further process.

• KOTRA may collect your personal information and send it to the Hiring Company. Your personal data is processed only for the purpose of the recruitment process.