To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites.
To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.
Master of Pharmacy Participation in Investigations, Root cause analysis and proposing relevant CAPAs against OOS: OOT: incident, and change control complaints and audit observations to QMS team.
Preparation of registration strategy for Brazil submission. Prepare response to deficiency letter received from Anvisa, Brazil. Sun Pharma, Executive Regulatory and Business Continuity
To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach.
Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.