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Hyderabad Area, India India

Regulatory and Operational Risk Consultant at Deloitte US(Offices of India)

Medical / Health Care / Pharmaceuticals

I work on validating (Computerized System Validation) IT applications implemented in the Life Sciences and Healthcare industry to make them compliant with the current regulations.I have a firm understanding of key FDA regulations,validation and testing activities required. My experience includes analysis of user requirements, risk analysis of requirements, review/authoring of key Validation deliverables and regression analysis. Hands on experience of HPALM 12.0, Enterprise JIRA. Specialties: 21CFR Part 11, Requirement Analysis, Data Migration Validation,Good Documentation Practices, change control, GxP Processes and Regulations,Gap Analysis,MHRA,ANVISA,Annex 11.