RESPONSIBILITIES
Coordinate project initiation meetings as per the scope defined by management.
To coordinate with the purchase team for timely availability of API /Excipients /Innovator /Generic products /Packaging materials/Imps/WS for development projects & Tech transfer projects
Coordinate for Licensing with R &D; & manufacturing location
To coordinate for BENOC with the clinical & R &D; team
Responsible for coordination and follow up with QC and analytical team for method development/validation/transfer activity.
To coordinate and follow up with the tech transfer team for scale up/submission/new product launch activity at the manufacturing site
Coordinate with the regulatory team for regular project related activities and query response/submission tracking
Responsible for the timely execution of the project as per the agreed plan
Regularly update on Project status to HOD
To maintain & update data of project related information.
Timely escalation to HOD for delay if any
Track milestones tracking for CMO projects for invoicing
DESIRED SKILLS
Should know the project management process
Good communication and problem solving skills
Valuable understanding of Formulation development & technology transfer process flow
Must have experience of regulatory submission requirements
Should know management information system
Robust technical presentations skills
Experience in customer relationship management
Should be willing to work in a dynamic work workplace