Hafida Fifi

I have a high interest in a career in regulatory affairs, with experience interning in Regulatory affairs at Kimia Farma, and preparing documents for the renewal registration process and variation registration.

• Prepare, review dossier for renewal and variation registration process 
• Review and ensure COA (Certificate of Analysis) and SOPs accordance with the latest regulations and pharmacopoeia 
• Coordinate with related departments for accordance with BPOM regulations and the latest pharmacopoeia 
• Create 20+ matrix comparations to pharmacopoeia 
• Ensure COA (Certificate of Analysis) and SOPs are accordance with the latest pharmacopoeia
• Analyze problems and create quality risk assessment report in Regulatory department 
•  Analyze organics and anorganics compounds trend in FDC tablet 

I've graduated Pharmacist from Muhammadiyah University of Surakarta on October 2023.