Divahar K Email and Phone Number

Generate equipment verification & validation protocols and reports as required. Review vendor documentation for completeness and accuracy.Participate in FAT and vendor related activities.Support issue resolution during equipment installation, commissioning, and qualification phases.Participate in verification & validation related activities as required. Support CQV execution team as needed.

Manufacture the Drug Substance with purification process by chromatography & Concentrate the product in TFF.Commissioning , decommissioning and Qualification of Equipment (CIP&SIP station, chromatography Column, Chromatography system, TFF system, Process Vessel, Cold room,etc) in Valgenesis software. Execute and Close the protocol & reports of the Equipment Qualifications in Valgenesis software and as always as paper Document. packing and Unpacking the Chromatography Column as per requirements ( Axichrom Column, Pall Column)

Process flow diagram, Piping and Instrumentation diagram, Time volume calculation preparation for new products and existing products for scale upIdentifying opportunities for adding value to New Product Development, Process Identification, Process Feasibility and Economic Analysis.Trouble shooting for new and existing products while new equipment commissioningTo prepare Trail batch report, Performance qualification batch report, HAZOP report, Incident investigation report and root cause identification and its CAPA implementation, Out of specification report.

Manufactured the Active Pharmaceutical ingredients as per the Batch manufacturing record. Follow the Good Manufacturing Practice and Good Documentation practice as per the company policy.Maintain and follow the clean room and gowning procedure. Added value to improve the Productivity and Quality of the product.