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55 Points
9 Years
User Activity
About 9 years ago
Commented on An amazing platform to build on but IAM policies, and cross account access needs improvement.
Please provide some info: on how you addressed IAM isssues - not clear
Comments
About 9 years ago
Infrastructure as a Service Clouds (IaaS)
About me
Direct Companywide Quality Systems in accordance with ISO standards and GxP, Manage Software Quality for development, release and maintenance (SDLC/SLC) for Enterprise / Cloud / SaaS andMobile Applications in accordance with GAMP5 CSV/Annex 11,PIC/S, HIPAA and SOX. Manage Internal and External Audits, RFP/Vendor Qualification, Training Program Management, CAPA and Design Control.
Revamped and standardized Quality Policy/Manual, SOPs and Lifecycle Processes (Agile/Iterative). Certified Auditor for Quality and Information Systems. Active membership -ASQ/ISACA/ISPE. Expertise in managing ISO/COBIT5/HIPAA/SOX assessments and remediation. Keen interest in Cyber security, cloud compliance, hosting provider qualification and SLAs/data center compliance audits and infrastructure qualification. Strong expertise auditing supplier and vendor sites.
Proficient in SAP, Supply Chain Track and Trace / Serialization, GS1/EPCIS/DSCSA compliance, MES for clinical materials, Manufacturing Control Systems (DCS/SCADA), LIMS, Oracle Clinical and Warehouse Management Systems.