What are the responsibilities and job description for the IM Regulatory Validation Lead position at Tekfortune Inc.?
Job Title: IM Regulatory Validation Lead Location: Raritan, NJ (Hybrid)
Job Details:
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
Salary : $50 - $60