L&T Infotech Jobs for Quality Specialist
Responsibilities including, but not limited to:
- Create a validation plan/test 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
- Dry run and execute test protocols. Review executed test scripts.
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Technical Requirements & Skills:
- 6+ 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 Clinical Operations system: CTMS, Aparito, Assitek, Clinical Studies Required
- 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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IT jobs