Prashanth Gowda Email & Phone Number

Bengaluru, Karnataka, India

Bangalore Urban, Karnataka, India

Currently working as Manager Microbiology department and Heading the Microbiology department for Shilpa Medicare Limited Unit VI, Unit III and Shilpa Therapeutics Private Limited.

Bengaluru, Karnataka, India

Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.I’m exposed to various Global Costumer Audits, Handling audit and compliance for Microbiology Department, Documentation Review and preparation of SOP , EOP, Specification and method of analysis based on requirements.Responsible for implementation of microbiological quality system.Manage the testing schedules of sample to meet the projected timeline. Also, ensures that all undertaken work is adequately reported, responsible for sampling and analysis of all microbiological quality system.Responsible for conducting internal audit.Support the business development team, through external presentations, meetings and technical input as required.Respond to queries from clients/regulatory agencies in a timely manner.Responsible for budget required for the department.Identify and justify CAPEX within the operations group to deliver projects.Attending the queries related to microbiology during audits.Identify, justify and select suitable candidates to perform the microbiological analysis and maintain quality in analysis.Ensure the technical expertise within the department gets involved in on-going professional development. Responsible for managing the transfer, application and validation of microbiological methodologies for in process samples, batch release and stability testing.Ensuring that an effective facility for environmental monitoring is in the place.Ensure staffs are trained appropriatelyMaintain and continually improve upon the quality of all microbiology activities.Maintenance and calibration of measuring/testing equipment belonging to the quality control microbiology laboratory is in co-ordination with maintenance department.Review /approve data, protocols and reports Writing/reviewing qualification/validation and method transfer protocols and reports.

Bangalore

In my total experience in Syngene I’m exposed to various Global Costumer Audits, Handling audit and compliance for Microbiology Department, Documentation Review and preparation of SOP , EOP, Specification and method of analysis based on requirements.Here I am responsible for leading a team of about 10 microbiologists in Quality Control microbiology laboratory and to participate in the investigation of complaints related to the quality of the product.Time management skill and work planning ability within the group, Ability to solve the problem and decision making skills, Manpower management and utilizations of skilled manpower.To participate in change control procedures on need basis and to initiate change controls, investigate incidents and deviations related to Microbiology aspects.Responsible for imparting training to subordinates as per SOP and on current GMP practices.Responsible for reporting to quality control manager on regular basis on compliance.To submit compliance of any of the non-compliance served by audit.Coordination, testing and reporting for all validation activity of production.To approve or hold or reject the finished product, in process bulk, final bulk, inactive raw material or active raw material.AHU Qualification and Equipment/ Instruments Qualification.Area Qualification and Water Qualifications.Preparation of method validation protocols based on regulatory requirements.Review, approval and release of microbiology analytical data of raw materials and finished products and trend analysis.Responsible for conducting Internal audit.Preparation of miscellaneous validation protocols for audit compliances.To lay down Quality Assurance system to ensure cGMP/ cGLP compliance at Plant/Quality control department as per quality standards.Quality analysis of food and food products as per HACCP/ FSSAI.

Bangalore

To look after day to day microbiological activities with respect to plant.To participate in the investigation of the outages pertaining to microbiological quality attributes.Exposure to quality management system such as change control, event and deviation, corrective and preventive action (CAPA).To prepare and implement the SOPs, protocols and specifications.To face the regulatory and the customer audits and to prepare the compliance for the observed points. Preparation of DQ, IQ, OQ and PQ documents.Preparation of area qualification protocol and environmental monitoring plans for production plants.Preparation of protocol, execution and final summary of routine revalidation and for ANDA batches. Review, approval and release the microbiology analytical data of sterile/ non sterile raw materials and sterile/ non sterile finished products.Preparation and maintenance of cGMP related documents. Procurement of medias, reagents, glassware and other requirements pertaining to microbiology section.Coordination with external agency for the routine revalidation of classified areas including Biosafety cabinets.Periodic re-qualification of equipments and manufacturing process. Monitor sterility testing of the product for raw material and primary packing materials.To carry out aseptic process validations.Handling of non-conformance and out of specification with proper documentation.Responsible for reporting of non-conformance with respect to environment/product and process to the quality control manager and follow up for rectification measure.Preparation, Implementation and verification of validation protocol related to qualification of equipment/instrument/area/personnel/system.Preparation and implementation of method validation protocol for Bacterial endotoxin test, Sterility testing, Antimicrobial Effectiveness Testing and other miscellaneous protocols.

Bangalore

To participate in the investigation of the outages pertaining to microbiological quality attributes.To prepare and implement the SOPs, protocols and specifications.To face the regulatory and the customer audits and to prepare the compliance for the observed points.Preparation of area qualification protocol and environmental monitoring plans for production plants.Review of microbiology analytical data of sterile/ non sterile raw materials and sterile/ non sterile finished products. Procurement of medias, reagents, glassware and other requirements pertaining to microbiology section.Periodic re-qualification of equipments and manufacturing process. Perform sterility testing of the product for raw material and primary packing materials.To carry out aseptic process validations.Handling of non-conformance and out of specification with proper documentation.Responsible for reporting of non-conformance with respect to environment/product and process to the quality control manager and follow up for rectification measure.Preparation, Implementation and verification of validation protocol related to qualification of equipment/instrument/area/personnel/system.Preparation and implementation of method validation protocol for Bacterial endotoxin test, Sterility testing, Antimicrobial Effectiveness Testing and other miscellaneous protocols.

Bengaluru Area, India

To prepare and implement the SOPs, protocols and specifications.Review of the log books related to microbiology.Environmental Monitoring: Routine monitoring of controlled environment by Active, Surface sampling and personnel monitoring. Non-viable air borne particulate matter monitoring of controlled environments using airborne particle counter.Water system: Routine analysis of potable water, purified water, water for injection for total Microbiological count and pathogens.Media preparation: Regular preparation, sterilization, storage and utilization of the media.Microbial limit test: Aseptic sampling of Raw Materials, water and routine analysis of MLT of Raw materials, semi-finished products, primary packing materials etc.Maintenance of cultures: sub-culturing (3 passages) and maintenance of cultures.Bacterial Endotoxin test: BET by gel clot technique using LAL reagents for WFI, Raw Material & finished products.

Bangalore

Microbiology testing of sterile/ non sterile raw materials and sterile/ non sterile finished products.To carry out sterility testing of the product, raw material and primary packing materials.Involved in aseptic process validations.Environmental Monitoring: Routine monitoring of controlled environment by Passive air sampling, Active air sampling, Surface sampling and personnel monitoring. Non-viable air borne particulate matter monitoring of controlled environments using airborne particle counter.Water system: Routine analysis of potable water, purified water, water for injection for total Microbiological count and pathogens.Media preparation: Regular preparation, sterilization, storage and utilization of the media.Microbial limit test: Aseptic sampling of Raw Materials, water and routine analysis of MLT of Raw materials, semi-finished products, primary packing materials etc.Maintenance of cultures: Procurement, sub-culturing (3 passages) and maintenance of cultures.Bacterial Endotoxin test: BET by gel clot technique using LAL reagents for WFI, Raw Material & finished products.