Job Details:
10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
Developing validation strategy for projects
Providing audit support and support Application Lifecycle Management
Managing/guiding/overseeing periodic checks
Ability to guide cross-functional teams and mentor junior staff
Broad experience in Computer System Validation (CSV) and testing
Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11
Clear written and verbal communication, especially for technical documentation
Acquainted with both the agile and waterfall software development methodology
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