- 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
- Good understanding of Formulation development & technology transfer process flow
- Must have experience of regulatory submission requirements
- Should know management information system
- Strong technical presentations skills
- Experience in customer relationship management
- Should be willing to work in a dynamic work workplace