Sarada Ramamoorthy
Head of Strategic Consulting, India at Compliance Group Inc
Based in India
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Seniority
C-Team
Department
General Business & Management
Location
India
Industry
Software Development
Company size
173
Contact information
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s•••••••@complianceg.com
Phone
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Background
About Sarada Ramamoorthy
Life Science Enthusiast with experience in Regulatory compliance and computer system validation/computer software assurance.Post Grad in Artificial Intelligence for Leaders from University of TexasGAMP, ISO 13485 (2003 and 2016), ITIL V3, V4 foundation, Certified Agile Scrum Master, Certified Agile Scrum Product Owner.ISO 27001:2013, ISO ISO 22301:2019 ISO:42001:2023 Certified.Experience in Validation of New IT like cloud, devops, AI, RPA, Audits and Assessments, Periodic Reviews, End to End GxP Validation for system/application development, Infrastructure Qualifications including SAP S4 Hana, SFDC. Change controls, operations and maintenance GxP reviews, Standard Operating Procedures, Life Sciences Training Management, QMS, CAPAS, Defect Management, Tool Qualifications - life cycle management, documentum, test management tools. Application/System Decommissioning Validations. Experience in managing/interpretations of FDA regulations like part 11, 820,210,211, 58, EU Annex 11, GDPR, Privacy Shield Requirments etc.
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