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CSV Specialist
PR/ US All
 

Responsibilities: • 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. Qualifications: • Bachelors’ 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. • Strong knowledge of laboratory systems is preferred.

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