Senior Consultant

LTM

4 weeks ago

Not enough detail in this posting to match

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
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

Senior Consultant · LTM