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Validation Analyst/ Business Analyst/ QA Anlayst

South San francisco, CA, 94080
75 $ per hour to my company
September 15, 2008

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Over seven years of diverse experience in Information Technology with emphasis on Validation and Software Quality Assurance on a wide range of applications.

• Good working experience in Computer Systems Validations (CSV) according to 21 CFR Part 11 and FDA regulations for Pharmaceutical and Biotech industries.

• Good understanding of cGxP environments like cGMP, cGLP and cGCP.

• Experienced in validating Medidata RAVE application.

• Experienced in validation of Business Objects XI R2 reports.

• Experienced in validation of Crystal Reports.

• Experienced in validation of EDC (Electronic Data Capture) applications.

• Experienced analyzing the System requirements and Business requirements and develop test plan and test cases out of the requirements.

• Experienced in developing validation protocols IQ, OQ, PQ for Computer System validation

• Reviewed the latest operating procedures of the company and developed SOPs.

• Hands on experience in all the activities of validation from Compliance Assessments to Validation Summary Report along with working knowledge in Remediation Plans and Retrospective Validation.

• Experienced in developing Requirements Traceability Matrix (RTM) and maintaining the Version control systems.

• Well versed in Document Change Control Techniques and methodologies.

• Experience in Periodical Review and Auditing of validation documents, Feasibility Study/Risk analysis and Remediation Process

• Experienced in User Acceptance testing (UAT).

• Good experience in testing the applications manually.

• Proficient in conducting GUI, Functional, Integration, System, Performance and Regression testing on various applications.

• Strong analytical, problem solving, interpersonal skills and quick learning abilities.

• Excellent Team player to work in conjunction with other testers, developers and other team members in validation and testing complex scenarios and projects and in the maintenance of Quality Standards in Projects.

• Excellent written, communication, interpersonal skills, proven team player with an analytical bent to problem solving and delivering solutions under high stress environment.

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