Computer System Validation Consultant with excellent functional proficiency in Process Compliance & Quality Assurance.
Broad range of experience includes Regulatory Risk Assessments, Quality Systems Implementation, Electronic Records and Electronic Signature (ERES) Compliance, Validation and Remediation of Laboratory, Clinical and Manufacturing Systems- Supply Chain ERP-SAP, LIMS.
Specialties: Computer System Validation Consulting, Process Engineering, Quality Audits, GAMP, Quality Assurance, 21 CFR Part 11,210,211,820, Quality Improvement, Gap Analysis, Testing and Validation, SAP Validation, Risk Compliance consulting,Verification and Validation