USDM validation analysts will support clients on a variety of compliance initiatives - Looking for resources with Argus/AERS experience.
Job Description • The validation analyst will provide an advisory role as needed. This may include: o Advising clients on assigning proper risk to computer systems o Advising clients on how to meet compliance requirements. o Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements. • Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements. • Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements • Develop test / validation scripts based on software / hardware design / configuration • Develop Installation tests / qualifications scripts based on Design • Develop Operation tests / qualifications scripts based on functional requirements • Develop Performance tests / qualification scripts based on configuration • Interact in a team environment, managing tasks and escalating issues as needed.