Aditya Shankar Panda

Experience

1. Executive Process Development and Technology Transfer

   Aurobindo Pharma Ltd

   Nov 2023 — Present · Jadcherla, IN

   A. Product transfer and process validation1. Preparation and approval of technical documents like BMR, BPR, Risk assessment, protocols for EB and trail batches, submission batch documents in support to regulatory2. Trial batch execution with all required documentation for generating scientific data to optimize critical parameters for product validation3. Support activities related to product transfer and process validations.4. Preparing and approval of technical reports, regulatory compliance documents, process validation reports, EB Summary reports.5. Review of annual reports.TECHNICAL IMPROVEMENTS1. Technical inputs and knowledge sharing with CFT\'s.2. Root cause analysis, trouble shooting of existing commercial batches and site transfer batches.3. Improving process capabilities, yields and process framing to achieve robustness and sustainability.4. Focus on various unit operations (equipment\'s) for achieving better efficiencies and performance.5. Preparation and review of OOS and OOT reports.OTHER KEY AREAS INCLUDE:1. Participate and provide support for internal and external audits, prepare documents for audit / inspection team as needed2. Work and coordinate with A team for closure and implementation of CAPA for incidents, deviations and audit observations.3. Participate in technical discussions during equipment procurement, project planning. risk assessment and system design etc.4.Explanation of risk assessment to auditor / inspection team as needed.5. Efficient knowledge on required software like QMS, E LOG, RISK MANAGEMENT SYSTEM, E RESIDUE PRO etc.6.Handaling of change control, QRM,PNC,CAPA.