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Job Title: Software Validation Analyst

Job ID: 201802

Job Duties:

Audit/review system validation life cycle and compliance related documents, such as Validation plan, IQ, OQ, PQ, User Requirement, Traceability Matrix, Change and Defective Management, Corrective and Preventive Action Review, Deviation, Verify, Sops, Coordinate and Implement of validation related activities of computerized systems/applications by working with Business users/SME and QA team in Healthcare Industry. Use knowledge of regulations such as GxPs, 21 CFR Part 11, 21 CFR Part 820, 21 CFR part 800, Annex11, ISO 13485 and GAMP Guidelines. Conduct and assist end to end application testing, including Unit Test, Regression Tests, System Tests, Quality Control tests and User Acceptance Tests using HP ALM.

Requirements:

MS in Biological/Pharmaceutical/Project Management. The Employer will accept any suitable combination of education, training, or experience.