Team Member MSAT

Dr Reddys laboratories 

• Participation in defining control strategies and performing risk assessment to identify the Critical Process Parameters and Critical Quality Attributes as part of QbD approach in validation batches for new products. Perform a thorough review of product development report and assess the risk involved during scale up studies and to propose risk mitigation plan for the identified/ anticipated risk.
• Responsible to Prepare a comprehensive technology transfer assessment report for products being transferred to new site which involves evaluating and documenting all aspects of the technology transfer process, including but not limited to, process methodologies, equipment requirements, facility conditions, and quality control measures. Ensure that the report provides a thorough analysis of the transfer's impact on product quality, regulatory compliance, and operational efficiency.
• Identify gaps between the two plants and conduct a gap assessment concerning processes, equipment, and facilities.
• Responsible for all the documents related to trials, process scale up, exhibit, pre-validation, validation of site transfer products – For preparation, data compilation, review and approval.
• Co-ordination with FR&D, Process development, MSAT,ASAT, AR&D, Quality Control, Quality Assurance, Production and Planning, Regulatory Affairs teams, FTL and  Supply chain management and other CFT’s to meet timeline as per requirements.
• Ensuring quality management system related activities pertaining to the site transfer products like Incidents, Change Control Notifications, Out of Specification and Out of Trend, Investigation Report preparation.
• Preparation and review of Technical Evaluation Report.
• Preparation of Hold Time / Stability Study Protocols & Reports for site transfer products.

B Pharm/M Pharm