Title:  Executive - Formulation Orals

Job Summary

• As a Product Robustness Review and Compliance Team member, work profile would be product robustness assessment, review of technical documents for all markets, harmonization related activities, compliance related activities
• Document management
• Should have knowledge of formulation development, statistics, statistical tools and knowledge of regulatory guidelines/requirements

Area Of Responsibility

• Review of technical documents for adequacy, raw data and quality of documents within defined SLA for regulated markets.
• Product Robustness Assessment.
• To perform and review statistical assessment using statistical tools such as JMP, Minitab for S1/S2 probability assessment, shelf life extrapolation, inverse extrapolation, DOE etc.
• Prepare, revise and review internal/ harmonised SOPs and guideline.
• Document Management- Provide document numbering and keep a record of the same as per SOP/guideline, issuance, archival and retrieval of documents & LNBs, inventory management for LNBs. Share historical data available in database with the team whenever required.
• Manage and provide inputs in Laserfische scanning of documents for EDAMS archival.
• Train the trainer activities.
• QMS related activities in track wise.
• EDMS related support