Lalit Patil

• Planning and Executing the activities at manufacturing and finishing area with cGMP & Safety Norms.
• Performed Scale Up Activities for Reaction, Filtration ,Crystallization ,Drying studies during launch and scale up.
• Handling manufacturing processes troubleshooting in plant by considering energy consumption, cost reduction , process optimization.
• Execution of Pre-validation and validation batches to meet the quality and yield.
• Investigation of OOS batches and filling a CAPA based on investigation and conclusion.
• Time cycle Management in manufacturing to achieve monthly targets.
• Catalyst Recovery (Pd/C) and improvement in recovery section through close operation monitoring.

· Technology absorption of new products for commercial scale up. (API and Intermediates)

· R&D and Process lab experiments for improvements

· Facility modifications, Equipment's and piping designing

· Provide Technical supports to Process Risk Assessment, Safety Review and HAZOP and PSM related studies

· Evaluation of process w.r.t Time cycle , yield and quality by monitoring critical process parameters

· Product Capacity planning

· Support to production team for cGMP, EHS and other necessary compliance

· Preparations of process engineering dockets, what if study reports and PSI and PHA documents

· Implementations of energy conservation techniques for cost optimization

· QMS Activities for installation of new facilities.

· Solvent Recovery Improvements

· Technology absorption of new products for commercial scale up. (API and Intermediates)

· R&D and Process lab experiments for improvements

· Facility modifications, Equipment's and piping designing

· Provide Technical supports to Process Risk Assessment, Safety Review and HAZOP and PSM related studies

· Evaluation of process w.r.t Time cycle , yield and quality by monitoring critical process parameters

· Product Capacity planning

· Support to production team for cGMP, EHS and other necessary compliance

· Preparations of process engineering dockets, what if study reports and PSI and PHA documents

· Implementations of energy conservation techniques for cost optimization

· QMS Activities for installation of new facilities.

· Solvent Recovery Improvements

· R&D and Process lab experiments for improvements

· Facility modifications, Equipment's and piping designing

· Provide Technical supports to Process Risk Assessment, Safety Review and HAZOP and PSM related studies

· Evaluation of process w.r.t Time cycle , yield and quality by monitoring critical process parameters

· Product Capacity planning

· Support to production team for cGMP, EHS and other necessary compliance