Debleena Mukherjee
Lead Engineer at Hcltech
Based in Chennai, India
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Seniority
Manager
Department
Engineering
Location
Chennai
Industry
IT Services and IT Consulting
Company size
258K
Contact information
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d•••••••@hcltech.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Debleena Mukherjee
I am currently working as Senior Reporting and Data Analyst in Medical Devices and Combination Products according to Good Documentation Practices.Holds experience in Complaint evaluation which includes determination of allegation type, problem coding and Hazard analysis and additional missing information details(GFE)Determination of Investigation of Complaint if it is necessary and perform root cause Analysis in Complaint Handling Management according to 21 CFR 803 standards.I have experience in Medical Device Reporting(MDR) according to EU Medical Device Regulations and as well as in FDA 21 CFR 820.I have experience in etmf-Clinical data Management and Metadata extraction in Clinical trail documents. Apart from this I possess good knowledge in Drug Delivery System, ICH GCP guidelines. I have completed PGDRA in regulatory affairs from GIRA. I love to learn new skills as well as I like to update myself to new technology and changes taking place across the globe.
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