AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation protocols (IQ/OQ/PQ), SOP's and Summary reports in compliance with GxP. * Proficient in Mercury Interactive Test suite (HP ALM). Expert in testing client server based applications on both UNIX and Windows environment. Proficient in preparing the test data to perform End-to-End testing (E2E) and product testing. Experience in testing with Informatica PowerCenter, PowerAnalyzer and Micro strategy tools Good understanding of data warehousing concepts. Expert in maintenance and updating of Test Scripts Experienced and good knowledge in all phases of software development project life cycle (SDLC). Writing and executing Test Plans, Test cases based on baseline requirements. * Enthusiastic, self-motivated, resourceful, highly organized, ability to multi-task, work under pressure and proficient in onsite/offshore coordination. * Excellent verbal, written communication, and presentation skills, analytical, problem solving and conflict resolution skills, and detail oriented.

Highlights:

• Compliance
• Test
• Test Cases
• Automation
• Documentation
• Protocol
• Risk Assessment
• Business Requirements
• SAS
• Test Plan