Computer System Validation

Support compliance activities such as preparing/reviewing validation documentation for identified systems with input from user's group, QA and IT.
Documentation writing that would include, but not limited to: Validation Plans, User Requirements, Functional Requirements, Design Specifications, Risk Assessments, IQ/OQ/PQ, UAT, Traceability Matrix, Validation Summary Reports.
Meet with users/project leaders to determine the intended use of the system, define business processes and define risk scenarios. Evaluate the system's landscape, architecture,software and hardware configuration,configurations and user roles.
Maintain effective computer change control and handle deviation reporting when unexpected events are found during execution of test scripts.
Requisitos:
Bachelor's Degree in Computer Science or some related scientific discipline. Experience in Computer Systems Validation and System Development Life Cycle methodology in a pharmaceutical or other FDA regulated industry.