RAJAGOPAL REDDY GANGASANI

• Production and Development of Ranibizumab, Dengue Vaccine.
• Period : 1+Month (, ).
• Location : Ekarajapura, Bangalore JOB RESPONSIBILITES.
• Production Activities:.
• Maintaining data of quality system (Deviation, change control and CAPA).
• Raising of deviation for any abnormalities and change control for any changes observed during process.
• Preparation of BMR, SOP, Annexure for production.
• Review of BMRs and submitted to IPQA.
• Responsible for shift manufacturing activities (UPSTREAM) with c-GMP and as per in house procedure.

• JOB RESPONSIBILITES.
• Production Activities:.
• Maintaining data of quality system (Deviation, change control and CAPA).
• Raising of deviation for any abnormalities and change control for any changes observed during process.
• Preparation of BMR, SOP, Annexure for production.
• Review of BMRs and submitted to IPQA.
• Responsible for shift manufacturing activities (UPSTREAM) with c-GMP and as per in house procedure.
• Reporting the shift activities to Manager, manufacturing operations.
• Media & Buffers & Seed preparation, fermentation, harvest.
• In process sampling and testing as per procedure.
• CIP and SIP of fermenters and process equipment’s.
• Ensuring the calibration and validation of instruments as per schedule.
• Involved in cleaning Validation.
• Performing regular EMP activities in process areas.
• Planning and execution of Daily activities.
• Handling of Continuous Centrifuge.
• Handling CHO Cell lines.
• Previous Organization - 3 : INTAS Pharmaceuticals Ltd (Biopharma Division).

Continuous centrifugation by Westfalia system

Monitoring of room temperatures, humidity and differential pressures.

Media & Buffers & Seed preparation, fermentation, harvest.

CIP and SIP of fermenters and process equipment’s.

Handling of Continuous Centrifuge, Batch Centrifuges and Homogenizers

• Production Activities:.
• Continuous centrifugation by Westfalia system.
• Monitoring of room temperatures, humidity and differential pressures.
• Media & Buffers & Seed preparation, fermentation, harvest.
• CIP and SIP of fermenters and process equipment’s.
• Handling of Continuous Centrifuge, Batch Centrifuges and Homogenizers, Development of pneumococcal Vaccine and EpCRM197.
• Period : 11 months (Oct 2017 to Sep 2018).
• Location : Hyderabad JOB RESPONSIBILITES.
• Glucose and Lactose analysis.
• RCB, SCB, MCB, WCB Cell banks preparation and execute suitability batches.
• Media & Buffers & Seed preparation, fermentation, harvest.
• CIP and SIP of fermenters and process equipment’s.
• Handling of Continuous Centrifuge, Batch Centrifuges and Homogenizers.
• 0.22µ filtration, depth filtration.

• Experience : Production of Whole cell Cholera Vaccine.
• Maintaining data of quality system (Deviation, change control and CAPA).
• Preparation of BMR, SOP, RST for production.
• Review of BMRs and submitted to IPQA.
• Good in handling of web-based tools like SAP.
• Responsible for shift manufacturing activities (UPSTREAM) with c-GMP and as per in house procedure.
• Reporting the shift activities to Manager, manufacturing operations.
• Seed preparation, fermentation, harvest and purification.
• Actively participated in Aseptic Process Simulation of cholera process using SCDM and WSL preparation.
• CIP and SIP of fermenters and process equipment’s.
• Cell washing by TFF system (0.2µ sartocubes) and Performing NWP for Sartocubes.
• Ensuring the calibration and validation of instruments as per schedule.
• Performing regular EMP activities in process areas.
• Planning and execution of Daily activities.
• Involved of the Gowning & Operator qualifications.
• EQUIPMENTS HANDLED.
• Operation of LAFU and Bio safety Cabinet.
• Watson Marlow pump (model: 620 Di, 323Dz).
• Mettler Toledo pH, Lab india and conductivity meter and Thermo scientific.
• Filter integrity testing of various filters by Sartocheck 4 and 4 plus (Make- Sartorius), Millipore and Palltronic flow star (Make-PALL).
• Spectrophotometer (Make-CECIL) and Shimadzu.
• Handling of various Fermenters: Sartorius.