IM Regulatory Validation Lead
Occupations:
Validation EngineersRegulatory Affairs ManagersCompliance ManagersSoftware Quality Assurance Analysts and TestersSoftware DevelopersIndustries:
Activities Related to Credit IntermediationGrantmaking and Giving ServicesProfessional and Commercial Equipment and Supplies Merchant WholesalersVocational Rehabilitation ServicesAccounting, Tax Preparation, Bookkeeping, and Payroll ServicesJob Title : IM Regulatory Validation LeadLocation : Raritan, NJ(Hybrid)Duration : Contract Job Description: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 areaAct 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 (GCP) 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