Kavitha B.
Principal, IT Quality at Novo Nordisk
Based in Plainsboro, United States
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Seniority
Other
Department
Other
Location
Plainsboro
Industry
Pharmaceutical Manufacturing
Company size
65K
Contact information
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k•••••••@novonordisk.com
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Background
About Kavitha B.
Results driven IT Quality Assurance professional specializing in Computerized Systems Validation (CSV) Compliance within the Pharmaceutical Industry. Expertise in interpreting and implementing regulatory requirements with a focus on employing risk-based validation methodologies. Proven leadership in independently managing CSV lifecycle and compliance for the US affiliate of a global pharmaceutical organization. Skilled in overseeing the complete CSV lifecycle, ensuring adherence to regulatory requirements, GxP best practices, and company policies. Effective communicator and collaborator, with a track record of leading QA-CSV teams, prioritizing vendor audits based on the risk assessments, and thriving in dynamic, fast-paced environments. Specialties: Computer System Validation/Compliance, Computer Software Assurance, Quality Assurance oversight, SDLC, Data Integrity, Change and Release Management, Risk Assessments, Gap Analysis and Remediation, GAMP, GxP, 21 CFR Part 11 compliance, Quality Management System, vendor audits
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