Ranganath P.

Validation Lead Compliance Lead Data Integrity Expert @Genentech

San Francisco, CA, US

Experienced Professional in Quality Systems, Enterprise level Business & IT systems, Software Tools with specialization in the areas of Computer Systems Validation and FDA regulations such as 21 CFR Part 11, 210, 211, 820, Data Integrity, Annex 11 guidelines, GxP (GMP, GLP & GCP) & GAMP5Experience in validation and implementation of Enterprise level Business/Quality systems - Calibration Manager (CalMan), Regulatory Asset Manager (RAM), Production Operation Management System (POMS), Batch Assay History Record (BAHR), Enterprise Service Bus (ESB), Doclink (EDMS), Reagent Recipe, Trackwise, Crystal Reports, Loftware, HP Quality Center, HP ALM, Automated Testing Tool-HP QTP & HP UFTKnowledge of overall processes, procedures and documentation needed for the Planning, Analysis, and Implementation through Retirement of systems in a regulated environmentAmerican Society for Quality (ASQ) certified ‘Quality Improvement Associate’ & ‘Quality Process Analyst’ & good knowledge of Industry standards like ISO Scrum Master (PSM I ) & Professional Scrum Product Owner (PSPO I)Project Planning, Resource Planning, Prioritization, Vendor Relationship Management, Process Improvement Initiatives, Internal/External Audits & Infrastructure/Application deploymentsStrong experience in developing end-to-end validation deliverables. Experience includes developing Validation Plan/Report, User Requirements, Functional Specification, Risk Assessments, Data Migration Plan/Report, Test Plan/Report, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Deviation Report, Traceability Matrix, Change Management, Periodic Reviews, Disaster Recovery Plan/Report, System Retirement Plan/Report & Validation RegistryExperienced in Change Control Management (CCM), Gap Analysis, Corrective and Preventive Action (CAPA) & Remediation Activities