Madhu Daparthi

About Madhu Daparthi

As an experienced professional, I have successfully navigated the intersection of…

Experience

1. IT Ot Validation

   Novo Nordisk

   Oct 2021 — Present · US

   Responsible for:Validation Activities: Develop and execute comprehensive validation plans, including risk assessments, test cases, and validation protocols.Regulatory Compliance: Ensure adherence to regulatory standards such as 21 CFR Part 11, GAMP 5, and other relevant guidelines.System Lifecycle Management: Manage the entire lifecycle of IT systems, from initial design and implementation to decommissioning.Documentation: Prepare and maintain detailed validation documentation, including validation plans, test scripts, and summary reports.Collaboration: Work closely with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation projects.Problem-Solving: Identify and resolve validation issues and deviations, implementing corrective and preventive actions.Audit Support: Support internal and external audits by providing validation documentation and addressing audit findings.

Education

• Jawaharlal Nehru Technological University

  Bachelor's degree, Chemical Engineering

  2000 — 2004

• Sullivan University

  Master's degree, Managing Information Technology

  2010 — 2012

Skills

• Computer System Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Validations
• Auditing
• Standard Operating Procedure (Sop)
• Management
• Medical Devices
• Capa
• Quality Assurance
• Corrective and Preventive Action (Capa)
• Ectd
• 21 Cfr Part 11
• Serialization
• Gmp
• Quality Management
• Regulatory Affairs
• Validation
• V&V
• Iso
• Change Control
• Pharmaceutical Industry
• Sop
• Fda
• Gxp