An IT Professional with 15+ years' experience in Regulated Environments Pharmaceutical, Medical Device, and Healthcare. Regulations Exposure: ISO 13485 and ISO 14969, HIPAA/EDI, JHACO, COBIT, GMP, IND, GCP-ICH, CEI - IEC, BS-EN standards, IND: 21CFR Part 58, 21CFR Part 201, 21 CFR Part 820, 21 CFR Part 11, GXP, SOX, CAPA, RUP. Compliance Applications: Oracle Argus Safety (AE), Trackwise (CAPA), Clinicopia (Clinical Investigators data), Oracle Clintrial (CDMS), Visual Source Safe (version ctrl), Qumas (version ctrl), Utopia, Agile Methodology, Rational Clearquest, Summit D (PM methodology), SDLC & ISLC (PM methodology) OS/Applications/Programming: Win10, Win7, XP, Vista, Win95, .Net, SAS, SAP, SQL, Oracle, Ms Office, Ms Project, Visio, Lotus Notes, Adobe Photo Shop and Illustrator, Cloud, Outlook, Ms Exchange, Snag It, IVR, Adobe, Crystal Reports, SharePoint, Drop Box, Google Apps.

Highlights:

• Inventory
• Project Management Office
• SAP
• Test
• Test Plans
• Business Analysis
• Business Analyst
• Business Requirements
• Compliance
• Information Technology