Karthik Chalapaka

Experience

• 

  Aurobindo Pharma

  Dec 2014 - now

  • Ensuring GLPand compliance for microbiology procedures in Quality lab.• Effective real-time review of logbooks and testing reports, method validations protocols.• All time readiness for regulatory audits and coordination for internal audits.• Tracking of Master calibration schedules and training identification matrix for ensuring Equipment and analyst Qualifications.• Document issuance, retrieval and tracking of batch related samples.• Co-ordination for change controls and Phase-1 investigations of OOS, OOT and follow up of Change control, Deviations and CAPA metrics.• Performance verification of all Microbiology lab related equipments ( Walk in type BOD incubators and Walk in type, cooling cabinet , BOD Incubators, Refrigerator, Freezer , Manual visual inspection hood, Water bath, Dry bath incubator,• Area qualification of viable and non viable particle count in aseptic area.• Hold Time Study Validation of Garments, Filling Items and Vessels after CIP and SIP.• Handling of Cleaning Validation , Process validation Samples• Water analysis of Water for injection ,Pure steam ,Purified water and feed water• BET • Media Preparation • Growth promotion Test• Performance verification, Calibration and Preventive Maintenance Program of Microbiology Lab Instruments• Disinfectant preparation, Fumigation • Environmental Monitoring of Critical areas by Active and passive air sampling, surface monitoring and personal monitoring.• HPHV, Vertical Autoclave PQ• BOD Incubator Validation • Water and Environmental monitoring trends preparation Show less

  • Executive

    Dec 2014 - now

  • Executive

    Dec 2014 - now