- 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

- Outstanding team player

Mandatory Skills : Regulatory & Compliance - Computer system validation

📌 Senior Consultant (Bengaluru)
🏢 LTM
📍 Bengaluru