Pradeep T Alwani

Sr. Validation Analyst at Eisai, Sr. Validation Analyst / Project Lead at Software Catalysts LLC

Greater New York City Area

Pharmaceuticals

Eisai since Jan 2013
Sr. Validation Analyst
Software Catalysts LLC since Nov 2006
Sr. Validation Analyst / Project Lead
BD Jun 2011 - Jan 2013
Validation Engineer
Accenture / Merck Mar 2011 - Jun 2011
Validation / Test Lead
Eisai Feb 2007 - Mar 2011
Sr. Validation Analyst

Illinois Institute of Technology 2001 - 2003
MS, Chemical Engineering Sardar Patel University 1996 - 2000
BE, Chemical Engineering Adarsh Maha Vidyalaya 1994 - 1996
Higher Secondary, Science

Computer System Validation
21 CFR Part 11
SAP
Clinical Trial Management
Clinical Trials
Technical Writing
CAPA
Gap Analysis
Remediation
Change Management
Change Control
Incident Management
FDA
Quality Auditing
Compliance Audits
Compliance Management
Validation
Quality Assurance
Quality Systems
LIMS
Medical Devices
Documentation
Pharmaceuticals
SDLC
SOP
Auditing
Testing
Business Analysis
MS Project
Life Sciences
Regulatory Affairs
Documentum
HPLC
Quality Management
Document Management
GAMP
ISO
Visio
Process Improvement
Compliance
Risk Management
EDC
HP Quality Center
Trackwise
SOX
GxP (GCP,GMP,GLP)
Data Migration
Software Project Management
Software Documentation
Sop