IM Regulatory Validation

Role 1 : Jr.

IM Regulatory Validation Lead Location:

Raritan, NJ (Hybrid)

Hire Type :

Contract Job Description Technical Lead is responsible for end-to-end technical ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 1. Work with cross functional team 2. Ensure all deliverables are met 3. Ensure Timeline is met, 2. Act as technical single point of contact for large regulatory programs 3. Understanding of Veeva (highly preferred) and AWS stack is a must. Role 2 :

IM Regulatory Validation Lead Location:

Raritan, NJ (Hybrid)

Hire Type :

Contract 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 Shyam Pachouri |

Senior Talent Acquisition Specialist Amaze Systems Inc D:

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