Kompella Ganesh

Microbiology
Key Result Areas:
® Day to Day Planning for Microbiological activities (Sterility, MLT, Water, Environmental monitoring)
® Shop floor monitoring activities for smooth functions of microbiology.
® Responsible for strengthening the Microbiology Department controls at site as per regulatory
requirements.
® Responsible for testing/monitoring of water and environmental conditions of the Manufacturing
area & Microbiology Laboratory.
® Responsible for Site Microbiology Control to check the authenticity of analysis results got by a
particular method of analysis applied to the product
® Supervise the activities and work of subordinates to ensure that all work within the department is
carried out in an efficient manner and in compliance with the set Policies and Procedures.
@ Maintain the proper safety standards, and cleanliness gowning inside Microbiology Laboratory.
® Review & Approval of Quality Control Microbiology documents and other relevant documents from
cross-functional teams.
® Review & Approval of Specifications, STPs, SOPs, GTPs, Miscellaneous study protocols and Risk
assessment.
Responsible for Internal and External audits.
Handling of sterility team, MLTS Bulk bio-burden, Environmental monitoring, water team activities.
Establishing procedures and ensuring implementation.
To conduct systemic evaluation/Inspection Management at site for Microbiology Labs for smooth
operations and inline practices.
@ Selection and development of team
for various activities like, analysis, validation, monitoring & audits.
® Method Validation of MLT, Bulk Bio-Load, and sterility protocols preparation, review and summary
preparation.
® Approvals in LIMS (Inprocess & Finished product). @ Conducting classroom trainings on SOPS.

® Day to Day Planning for Microbiological activities (Sterility, MLT, Water, Media preparation) @ Shop
floor monitoring activities for smooth functions of microbiology.
® Responsible for strengthening the Microbiology Department controls at site as per regulatory
requirements.
® Responsible for testing/monitoring of water and environmental conditions of the Manufacturing area &
Microbiology Laboratory.
® Responsible for Site Microbiology Control to check the authenticity of analysis results got by a
particular method of analysis applied to the product
® Supervise the activities and work of subordinates to ensure that all work within the department is
carried out in an efficient manner and in compliance with the set Policies and Procedures
@ Maintain the proper safety standards, and cleanliness gowning inside Microbiology Laboratory.
® Review of Quality Control Microbiology documents and other relevant documents from cross-functional
teams.
® Review & Approval of Specifications, STPs, SOPs, GTPs, Miscellaneous study protocols and Risk
assessment.
® Responsible for Internal and External audits.
® Execution of Media fill & Investigation of Media Fill failure.
® Handling of sterility team, MLT& Bulk bio-burden, water team activities.
® Establishing procedures and ensuring implementation.
® To conduct systemic evaluation/Inspection Management at site for Microbiology Labs for smooth
operations and inline practices.
@ Selection and development of team
for various activities like, analysis, validation, monitoring & audits.
® Method Validation of MLT, Bulk Bio-Load, and sterility protocols preparation, review and summary
preparation.

® Review of Quality Control Microbiology documents and other relevant documents from cross-functional
teams.
Evaluation of disinfectant
for sanitization and Disinfectant qualification.
Review of Specifications, STPs, SOPs, GTPs, Miscellaneous study protocols and Risk assessment. @
Execution of Media fil & Investigation of Media Fil failure and Review of aseptic activities (CCTV) @
Involved in Gap Analysis & Preparation of the rationale for reduced sampling/ Testing.
Review of Quality Microbiology documents and other relevant documents from cross-functional teams.
Ensure the GLP and GDP in the laboratory.
Evaluation of disinfectant for sanitization of area.
Coordination of Validation and qualification activities and review of Validation and qualification
documents.
® Documentation and ensure accuracy, integrity and reliability of laboratory data
® Method Validation of Microbial limit test. Microbial limit test for finished products, Raw material,
Stability sample and packing material. (Harmonized Methods). Microbiological identification of
pathogens. @ Water sampling and testing by pour plate method and membrane filtration method.
@ sterility Testing by Membrane Filtration and Direct Inoculation Method.
® Microbial Enumeration Test.
@ Handing of Cultures, Culture suspension and Culture identification.
® Receipt, Storage and maintenance of dehydrated media. @ CCIT (Container Closure Integrity Test) @
Handling of Biological Indicators.
® Environmental Monitoring in MFG Area, Microbiology Department.
® Environmental Monitoring sampling methods followed by Passive Air sampling, Active Air sampling,
Surface sampling and Personnel monitoring.
® Area Qualifications.
® Water and Environmental Monitoring trend and summary preparation.
@ Establishment of an Environmental Monitoring program through rationale (Active, Passive, Surface and
Personnel) and establishing their trend data.

® Media preparation.
® Milk analysis by pour plate Method.
® Pathogen testing.
® MBRT test.
® Phosphate Test.
@ Trend and summary preparation.
® Establishing procedures and ensuring implementation.
. Documentation and ensure accuracy, integrity and reliability of laboratory data.