Sr. Quality Consultant
CurrentResponsible for coordinating compliance activities and audits by working with various internal groups of client organizations and outside auditors.Provide GCLP/GCP and ISO compliance and auditing support by performing audits of manufacturing floors, laboratory facilities, generate reports and data for executive managementSetup framework and implement CAPA (Corrective Action Preventative Action) framework for client organizationsDevelop, re-engineer processes and SOPs including protocols, amendments, sample case report forms, and sample informed consent forms for adequacy and compliance.