Senior Consultant

• Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable

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• 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

• 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