Dinesh Gokavarapu
Manager @CuraTeQ Biologics
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WORK HISTORY
Manager @CuraTeQ Biologics
Hyderabad, IN
EDUCATION
Gitam
B.Tech, Biotechnology
Sathyabama university
Master of Technology (M.Tech.), Biotechnology
SKILLS
ABOUT DINESH GOKAVARAPU
Well Skilled in Quality assurance with 12+ years of experience in Bio-pharmaceutical industry (MABs) and projects handled for mammalian product commercialization are trastuzumab, bevacizumab, Nimotuzumab, Itolizumab, Adalimumab and experienced in major regulatory audits like USFDA, EMA, Health Canada.The area of expertise include:· Proficient knowledge in IPQA related activities (Line Clearance, Online Process Monitoring during Batch manufacturing).Handling of Batch disposition activities in SAP and ERP.· Review and Approval of manufacturing Records(BMR, MFR)· Knowledge in Quality Management system (QMS),Handling of Investigations/ Root cause analysis and CAPA of deviations and OOS/OOT. Knowledge in process validation & Cleaning Validation· Knowledge in Routine GMP visits in the facility and ensuring the GMP at work place.· Handling of SAP Related Activities (Material Management, Quality Management)· Knowledge in Risk assessment document of TSE/BSE
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