Regulatory Officer

Octarine


Tanggal: 17 jam yang lalu
Kota: Pekerjaan jarak jauh, Pekerjaan jarak jauh
Jenis kontrak: Penuh waktu
Jarak jauh
Responsibilities

  • 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.

Requirements

  • 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.

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