Badiganti Prapulla Kumar

Experience

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  Divis laboratories ltd

  May 2012 - Jun 2015

  Production Supervisor

  Preparation & Review of Master Batch production records in line with the technical package / modified process. Review of executed BMR and related documentation with respect to shop floor operations and QMS involves ensuring that production processes are executed according to established procedures and regulatory requirements.Imparting the training on approved documents and ensuring training is completed prior to the execution of documents.Having knowledge on ICH guidelines (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), cGMP (Current Good Manufacturing Practices) systems and computerized system validation.Preparation and review of standard operating procedures with strengthening.Followed the manufacturing operations with DCS - Handled the Reactors, Agitated vessels, Driers, Filtration equipment and Powder processing equipment.Handled the Distillation columns.Prepared Daily, weekly & monthly metrics and performed analysis on the production activities. Show less

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  Piramal Enterprises Limited

  Aug 2015 - Dec 2017

  Executive

  Preparation & Review of Master Batch production records in line with the technical package / modified process. Review of executed BMR and related documentation with respect to shop floor operations and QMS involves ensuring that production processes are executed according to established procedures and regulatory requirements.Imparting the training on approved documents and ensuring training is completed prior to the execution of documents.Having knowledge on ICH guidelines (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), cGMP (Current Good Manufacturing Practices) systems and computerized system validation.Preparation and review of standard operating procedures with strengthening.Followed the manufacturing operations with DCS - Handled the Reactors, Agitated vessels, Driers, Filtration equipment and Powder processing equipment.Handled the Distillation columns. Show less

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  Hikal Ltd

  Apr 2018 - Apr 2020

  Production Incharge

  Preparation and review of standard operating procedures with strengthening.To ensure implementation of corrective actions and preventive actions for raised non-conformities.Handling of production related activities in ERP – SAP PP module: BOM Creation and revision.To co-ordinate with QA, QC, Maintenance, Warehouse and PETT for smooth operation of day-to-day production activities with respect to required documents for execution.Having knowledge on ICH guidelines (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), cGMP (Current Good Manufacturing Practices) systems and computerized system validation.Handed the investigations with respect to out of specifications and deviations of process, facility and procedures.Preparation and review of risk assessments for process, investigations & regulatory requirements and associated CAPA.Management of change controls with respect to process, facility and procedures.Involved in commissioning and Qualification of equipment and computerized system validations in Green-field project.Involved in regulatory inspection of USFDA, Health Canada, EDQM, TGA, PMDA and various customer audits & Execution of compliance report.Preparation & Review of Master Batch production records in line with the technical package / modified process. Review of executed BMR and related documentation with respect to shop floor operations and QMS involves ensuring that production processes are executed according to established procedures and regulatory requirements. Show less

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  Biocon

  Apr 2020 - now

  Operational Quality Member

  Preparation and review of standard operating procedures with strengthening.Review of executed batch production records, Area / equipment qualification, Temperature mapping documents and verifying the procedures compliance.Maintain accurate and up-to date documentation related to corporate audits and regulatory compliance, ensuring completeness and accessibility for stakeholders.Plant rounds to identify the gaps with respect to good manufacturing practices.Knowledge on large-scale fermentation processes for the product manufacturing.Knowledge on Inoculum preparation, ensuring consistency and purity of seed cultures for optimal production yields. Oversee and manage Quality management system tasks within the site Quality assurance.To ensure implementation of corrective actions and preventive actions for raised non-conformities.To monitor the progress of various projects in the manufacturing blocks.Addressing the possibilities for upgrade of quality and productivity.Handling of production related activities in ERP – SAP PP module: BOM Creation and revision.To co-ordinate with CFT for smooth operation of day-to-day production activities with respect to required documents for execution.Execution and monitoring the critical Utility (Nitrogen, Compressed air and process steam) Qualification and periodical testing as per defined frequency.Pre-Audit of production blocks to preparation for internal, customer and Regulatory audits.Having knowledge on ICH guidelines (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), cGMP systems and computerized system validation.Preparation and review of risk assessments for process, investigations & regulatory requirements and associated CAPA.Management of change controls with respect to process, facility and procedures.Involved in regulatory inspection of USFDA, Health Canada, EDQM, TGA, PMDA and various customer audits & Execution of compliance report. Show less