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Specialist - Quality Engineering

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Date: Sep 24, 2022

Location: Baltimore, MD, US

Company: Larsen & Toubro Infotech Ltd

Computer System Validation (CSV), shall able to develop, review validation deliverables; manage IT Change Requests, Deviations, CAPA; dry run, execute test protocols.

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 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 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

Nearest Major Market: Baltimore

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