IM Regulatory Validation Lead
Raritan, New Jersey, United States of America
Contract
1 week ago
Key skills
GoAWSGoogle CloudJiraSDLCCommunicationProblem Solving
About this role
Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack
• 8+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Act as single point of accountability for validation deliverables,
• Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
• Developing validation strategy for projects
• Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed
• Providing audit support and support Application Lifecycle Management
• Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations
• Ability to guide cross-functional teams
• Broad experience in Computer System Validation (CSV) and testing
• Acquainted with Good Clinical Practices (Google Cloud Platform) regulatory requirements and FDA 21 CFR Part 11
• Clear written and verbal communication, especially for technical documentation
• Solid understanding of the fundamentals of iterative and incremental software development
• Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
• Skilled in project planning, execution and minimal rework strategies
• Capable of risk identification and mitigation, especially in regulated environments
• Strong Analytical and Problem solving
• 8+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Act as single point of accountability for validation deliverables,
• Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
• Developing validation strategy for projects
• Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed
• Providing audit support and support Application Lifecycle Management
• Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations
• Ability to guide cross-functional teams
• Broad experience in Computer System Validation (CSV) and testing
• Acquainted with Good Clinical Practices (Google Cloud Platform) regulatory requirements and FDA 21 CFR Part 11
• Clear written and verbal communication, especially for technical documentation
• Solid understanding of the fundamentals of iterative and incremental software development
• Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
• Skilled in project planning, execution and minimal rework strategies
• Capable of risk identification and mitigation, especially in regulated environments
• Strong Analytical and Problem solving