• Audit and confirm compliance of Active substance and starting materials are in line with ICH Q7. 
  • Review of OOS/OOT report and assess the effectiveness of the proposed CAPA
  • Post approval surveillance audits as per risk assessment. Establish robust key performance index to evaluate, track record and rating for suppliers.
  • Support Purchase team to evaluate new suppliers.
  • Support R&D for development of robust API by setting up analytical controls at appropriate stages and in Starting/raw materials.