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Specialist - Quality Engineering

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Date: Jun 11, 2021

Location: Airoli, MH, IN

Company: Larsen & Toubro Infotech Ltd

Responsibilities including, but not limited to: • Create a validation plan using a risk-based approach. • Create a validation report that verifies compliance to the plan. • Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable. • Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached. • Write, review, evaluate the configuration management plans and procedures associated with the development process. • Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix. • Raising a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per Ultragenyx SOP; Reviewing and verify execution of CR; Monitoring CR through closure • Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per Ultragenyx SOP. • Raising an IT CAPA, initiation, action processing, root cause analysis. • Monitoring deviations and CAPAs for extension, amendment, approval, and closure. • Conduct post-implementation; periodic review of systems. • Dry run and execute test protocols. Review executed test scripts. Technical Requirements & Skills: • 8+ years of relevant experience • Hand on experience of supporting Computer System Validation • Experience with industry-standard and best practices regarding quality, quality assurance and quality control principles and techniques (e.g., 21 CFR Part 11, GAMP 5) • Knowledge of GxP best practices, international standards to quality management and methodology. • Experience supporting computer system validation work related to Oracle ERP system (Optional) • Proven experience collaborating with others, including employees and contractors • Effective communication skills (written and oral) • Effective and independent problem-solving skills • Great team player


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