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Specialist - Quality Engineering

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Date: Sep 23, 2022

Location: Woburn, MA, US

Company: Larsen & Toubro Infotech Ltd

Work on CSV requirements for the laboratory applications and Benchtop equipment which includes software applications like Labvantage, CMMS, EDR, JMP and Kinaxis.

Below are the overall Responsibilities

• 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 customer’s 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 customer’s 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.

• Qualification of Manufacturing Equipment

• Backup and Restore testing support


Nearest Major Market: Woburn
Nearest Secondary Market: Boston

Job Segment: Testing, Quality Engineer, CAPA, Engineer, Technology, Engineering, Management