Urvesh Chaudhari
Senior Validation Executive at Gamp Services
Based in Ahmedabad, India
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Seniority
Manager
Department
Operations
Location
Ahmedabad
Industry
—
Company size
50
Contact information
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u•••••••@gampservices.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Urvesh Chaudhari
Providing Quality and Compliance expertise to ensure system compliance with requirements. Good Understanding of FDA 21CFR Part 11, EU Annex 11, ISO 13485. Experience in understanding requirement and writing test cases and executing them. Experience of Process Control Systems (PLC,HMI,SCADA,DCS,Microcontroller based) Experience of Desktop Qualification Experience of Server Qualification Experience of ERP Validation (Progen ERP) Experience of Track and Trace Systems Experience of Document Management System (SoftSign 2.0) Experience of Laboratory Systems Experience of Medical Devices Qualification Experience of Infrastructure Qualification Experience of Excel Sheet Validation Experience of Data Migration Activity Hands on experience in GAP Assessment & Remediation as per 21 CFR Part 11/ Annex 11 Compliance. Hands on experience in Risk Assessment, review of SOPs to ensure their completeness, clarity and compliance, Data Integrity compliance.
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