Regulatory Officer
Octarine Perfume
Lokasi
Bogor
Tipe kerja
On-site
Gaji
Dirahasiakan
Deskripsi pekerjaan
- Manage product notification registration with BPOM.
- Prepare and maintain the Product Information File (PIF/DIP) documentation.
- Monitor the completeness, accuracy, and updates of PIF/DIP and BPOM notification documentation.
- Prepare and submit Production Reports and MESKOS Reports to BPOM on a semi-annual basis.
- Prepare and report alcohol usage documentation in compliance with applicable regulations.
- Prepare Material Safety Data Sheets (MSDS) to support product distribution requirements.
- Prepare Certificates of Analysis (CoA) as supporting documentation, including for air freight shipments.
Persyaratan
- Bachelor's degree in Pharmacy or a licensed Pharmacist (Apoteker).
- Minimum 2 years of experience in a similar role.
- Certified in Product Information File (PIF/DIP) and Cosmetic Safety Assessment, with the ability to perform Margin of Safety (MoS) calculations.
- Strong understanding of cosmetic regulations and cosmetic raw materials.
- Good knowledge of CPKB (Good Manufacturing Practices for Cosmetics), Halal Assurance System, ISO standards, and 5R workplace organization principles.
Keahlian yang Dibutuhkan
Risk ManagementReport WritingRegulatory CompliancePolicy Development
Benefit & Fasilitas
competitiveSalarymedicalLeavebonusSystempaidSickDays
