About Emmanuvel V S:
Preparation and review of system level impact assessment and risk assessment, master qualification protocol, design qualification, installation qualification, operational qualification, performance qualification for various equipment's like Harvest vessel tank, Process tanks, Media preparation vessels, NDV's, Fermenters, CIP skids etc Preparation, review and operations of laboratory instruments like weighing balance, pH meter, Lab centrifuge, UV spectrometer Preparation, review and operations of process tanks, mobile tanks Preparation and review of department related SOP's Review of FAT and SAT documents Supporting role for qualification of AHU and force draft ventilations Filter integrity- I handled different type of filters integrity tests like WIT and BPT Operating and monitoring the fermentation via DCS, SCADA and PLC Performing CIP and SIP of Production Equipment's,vessels Maintaining Equipment usage log books and status boards FS writing and valve matrix preparation Handling the fermentation in the range of 50L to 30000L capacity Record all observations data and prepare batch records, BMR, Sop Independently looked after shift working and troubleshooting of the process Ensured all safety aspects in plant including handling of hazardous chemicals by workers Knowledge of cGMP, EHS, MSDS &PPE Following EHS rules and regulations Documentation: Regulatory, Production batch BMR
Experience
Preparation and review of system level impact assessment and risk assessment, master qualification protocol, design qualification, installation qualification, operational qualification, performance qualification for various equipment's like Harvest vessel tank, Process tanks, Media preparation vessels, NDV's, Fermenters, CIP skids etc Preparation, review and operations of laboratory instruments like weighing balance, pH meter, Lab centrifuge, UV spectrometer Preparation, review and operations of process tanks, mobile tanks Preparation and review of department related SOP's Review of FAT and SAT documents Supporting role for qualification of AHU and force draft ventilations Filter integrity- I handled different type of filters integrity tests like WIT and BPT Operating and monitoring the fermentation via DCS, SCADA and PLC Performing CIP and SIP of Production Equipment's,vessels Maintaining Equipment usage log books and status boards FS writing and valve matrix preparation Handling the fermentation in the range of 50L to 30000L capacity Record all observations data and prepare batch records, BMR, Sop Independently looked after shift working and troubleshooting of the process Ensured all safety aspects in plant including handling of hazardous chemicals by workers Knowledge of cGMP, EHS, MSDS &PPE Following EHS rules and regulations Documentation: Regulatory, Production batch BMR
Education
Diploma In chemical engineering
Professionals in the same Pharmaceutical / Bio-tech sector as Emmanuvel V S
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