AddressResponsible for process development and scale up of product technology of transdermal patches and oral films.
Responsible for Documentation and execution of Scale up, exhibit, engineering, and validation batches of Transdermal Patches and Oral Films.
Preparation of Risk assessments, sampling protocol and various study protocols.
Optimization of process parameters using Design of experiment software.
Responsible for hold time study data generation and documentation.
Responsible for initiation and closure of QMS activities such as Deviations, Change Control, Incident etc.
Responsible to provide trainings to cross functional teams.
Preparation and Review of study protocols, batch manufacturing records and reports.
Coordination with cross functional teams for smooth and timely completion of project.
Support for regulatory filing. & Support in F&D trials.
Monitoring of batches as per production planning.
