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Validation Lead II Validation Lead II
Ref No.: 18-14115
Location: Bridgewater, New Jersey
Responsible for creation and maintenance of all system-related documentation to support the ACES Medical 2012 Project October release.. The scope of this documentation includes - User and Functional Requirements Specifications, System Design Specifications, Requirements Traceability Matrices, Operational Qualification test cases, Process Qualification test cases and system training materials. Responsible for managing system documentation review, storage, versioning and signature collection. Interact with end users to gather business requirements and information and transcribe them into validation requirements. Responsible for analyzing different use cases and developing requirements. Must have very good analytical skills to analyze requirements to develop both positive and negative testing scenarios. Perform Good Documentation Practices review of all test cases post execution. Manage the creation of and/or updates to system documentation in accordance with regulatory requirements for all functional objects, scripts created such that systems maintain their regulated status. Understand documentation requirements by working closely with corporate IS QA and corporate Quality and Compliance representatives, maintaining the documents according to corporate SOPs. Learn, test, and challenge software development products and interface with technical staff to document concepts, procedures, and reference materials as well as create examples and index the written material. Experience: 3 to 6 years.

Validation and PUMA methodolgy