Senior Consultant

Responsibilities

• 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 customers SOP
• Reviewing and verify execution of CR
• Monitoring CR through closure
• Monitoring deviations and CAPAs for extension amendment approval and closure
• Conduct postimplementation periodic review of systems
• Dry run and execute test protocols
• Review executed test scripts

Requirements

• 3-5 years of relevant experience
• Hand on experience of supporting Computer System Validation
• Experience with industrystandard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5
• Knowledge of GxP best practices international standards to quality management and methodology
• Proven experience collaborating with others including employees and contractors
• Effective communication skills written and oral
• Effective and independent problemsolving skills
• Great team player

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