Formulation department for handling solid oral dosage forms aimed for US and other regulated markets from its initial stage in all aspects like induction & building of new team, procurement of all required equipments & instruments, detailed time line planning for the development of the projects.
Managing and providing guidance to a team members from the conception of a new project till its submission to the respective markets.
Implementation of QbD initiatives for successful Qbd filings from the site.
Preparation & monitoring of Capex & Revenue Budgets for the department.
Coordination with the respective departments based in India, US & EU counterparts etc.
Responsible for Technology Transfer team for transfer of products to commercial scale.
Responsible for query reply of different Regulatory bodies and co-ordinating with Regulatory Affairs department to fulfill requirement of dossier submissions.
Handling of investigations, troubleshooting and implementation of solutions.