The candidate responsibilities include mainly writing test cases based on functional specifications and executing test scripts to ensure the system release functions as expected by company. The candidate should:
Demonstrate attention to detail and accountability.
Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
Identify and escalate, as necessary project risks and issues to the Validation Lead and/or Project Manager.
Be able to prepare reports on defects and problems that arise during system testing.
Have solid oral and written communication skills and teamwork skills.
Be a good team player, able to meet deadlines and handle changing priorities.
Have strong judgment capabilities to clarify requirements when necessary.
Have the ability to work with IT management, business analysts and technical staff.
Have solid experience working with validated systems
Work with business representatives to ensure the test cases reflect business rules and processes
Revise test cases as necessary based on project team feedback.
Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.
Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.
As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity
Required Qualifications:
Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
Highly skilled in Computerized System testing and validation in the healthcare industry.
The candidate must have experience with Quality Center and understand the SDLC processes.
Experience with TrackWise is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications.
Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.)
Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
Excellent communication including written, verbal, and listening skills.
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
HP Quality Center
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