Responsibilities including, but not limited to:
• Create a validation 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 SOP; Reviewing and verify execution of CR; Monitoring CR through closure
• Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per SOP.
• Raising an IT CAPA, initiation, action processing, root cause analysis.
• Monitoring deviations and CAPAs for extension, amendment, approval, and closure.
• Conduct post-implementation; periodic review of systems.
• Dry run and execute test protocols. Review executed test scripts.
Technical Requirements & Skills:
• 8+ 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 Oracle ERP system (Optional)
• Proven experience collaborating with others, including employees and contractors
• Effective communication skills (written and oral)
• Effective and independent problem-solving skills
• Great team player