Support system for Formulation development team & Technology transfer team for development of commercially feasible & robust process.
o Participation in Process DOE & QbD documentation.
o Review of analytical data and further action plan related to process development.
o Review of documents such as finished product specification
(FPS), Data sheet, feasibility Guidelines, Authorized guidelines.
o Ensure successful execution and continual monitoring of technology transfer from R & D scale to Regulatory batch manufacturing and from Regulatory batch manufacturing to Commercial batch manufacturing.
o Response to process related queries (along with FD - Quality assurance dept) related to product development for all markets, such as US, EU etc.
o Training for any new dosage forms/ systems/ technologies introduced.
o Training to other Formulation development groups, as and when required.
o Involvement in technical discussion with suppliers/ customers.
o Process optimization and evaluation by applying statistical parameters such as CpK, sigma level, yield improvement and robustness of process.
o Implementation of Post approval changes.