Balaji Rajput Email and Phone Number

-Managing wide range of injectable drug product in Drug device combination portfolio in pipeline viz. Biological & Biosimilar into drug device combination at In-House R&D & CMO.-Drive CRO & CMO projects across different manufacturing sites.-Maintaining and implementing Quality Management System (QMS) which includes Department Training Coordinator, Change management (change control), investigation and root cause analysis and document control and ensuring they meet applicable regulations… Show more -Managing wide range of injectable drug product in Drug device combination portfolio in pipeline viz. Biological & Biosimilar into drug device combination at In-House R&D & CMO.-Drive CRO & CMO projects across different manufacturing sites.-Maintaining and implementing Quality Management System (QMS) which includes Department Training Coordinator, Change management (change control), investigation and root cause analysis and document control and ensuring they meet applicable regulations and guidelines.-Preparation and review Protocol for trials, study, scale-up and submission batches Pre- execution and Post- execution.-Responsible for collection of analytical data and interpretation of results and Prepare Reports for, scale-up batches & execute the Development, PV, IMPD batches.-Having good working knowledge of gap analysis, troubleshooting, decision making ability,strategies, & principles.- Regulatory Support for on-time filing and Dossier Submission.- Regulatory support BLA Filing*Skills: • Device Design & Development • Troubleshooting • ISO 11608 • ISO 11040 • ICH Q9,Q7 & Q 5• 3D Designing • Data Analysis • Operational Excellence • Continuous Improvement • Cross-functional Collaborations • Training Management • Change Impact Analysis • Process Equipment • Process Validation • Process Transfer • Business Process Management • Research Skills • Team Leadership • Processes Development • Communication • Internal Audits • Failure Mode and Effects Analysis (FMEA) • Preventive Actions • Quality Reviews • • Analytical Skills • Interpersonal Skills • Problem Solving • Corrective Actions • GXP • Regulatory Compliance • SAP Document Management System (DMS) • Product Lifecycle Management • Risk Assessment • Good Manufacturing Practice (GMP) • Project Management • Process Improvement • Product Development • Troubleshooting • Standard Operating Procedure (SOP) • Technology Transfer • Leadership Show less

-Drug Product Manufacturing Science and Technology (DP MSAT)-GMP documents Preparation-Troubleshoot the Operations with root cause Analysis.-Provide Technical Support to the Manufacturing unit.-Parentral Drug Delivery, Injectable's-cGMP, Process Validation Batch Execution-Six Sigma Methodology-Drug-Device Combination Product -Therapeutic Protein and insulin Analogue biological Product Manufacturing.*Skills: • Device Design & Development… Show more -Drug Product Manufacturing Science and Technology (DP MSAT)-GMP documents Preparation-Troubleshoot the Operations with root cause Analysis.-Provide Technical Support to the Manufacturing unit.-Parentral Drug Delivery, Injectable's-cGMP, Process Validation Batch Execution-Six Sigma Methodology-Drug-Device Combination Product -Therapeutic Protein and insulin Analogue biological Product Manufacturing.*Skills: • Device Design & Development • Troubleshooting • ISO 11608 • ISO 11040 • ICH Q9,Q7 & Q 5• Process Development • Technical Documentation • Investigation • Continuous Improvement • Research Skills • Process Development • Communication • Failure Mode and Effects Analysis (FMEA) • Analytical Skills • Interpersonal Skills • Problem Solving •GxP • Regulatory Compliance • Risk Assessment • Good Manufacturing Practice (GMP) •Process Improvement • Product Development • Troubleshooting • Standard Operating Procedure (SOP) • Technology Transfer Show less

-Design & Development Of Biological Sensors- Optimization Real-time Monitoring Devices -Prototypes Development- SOP Preparation-Research On Analyte Interaction-Development of smart Sensors-Research On Nanotechnology