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Updated: 2023-09-12
Technical Validation Lead
Deerfield, IL
- Offentliggjort 3 years ago
- Engelsk
- Forventet startdato: Hurtigst muligt
Assignment Details
Job Summary:
The candidate responsibilities include mainly writing, executing test cases based on functional specifications and managing the validation/test phase to ensure the system release functions as expected by Baxter. 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 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
- Revise test cases as necessary based on project team feedback.
- Work closely with the 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
- Manage the entire testing phase: validation analysts, assignments, progress, etc.
- Develop and execute system test cases, scripts and plans.
- Understand and follow appropriate SDLC, quality validation processes and application processes.
- Familiar and capable of trace matrix generation
- Support IT technical and IT validation teams for the development of the functional specifications and the functional testing
Responsibilities:
- 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 HPALM and understand the SDLC processes.
- Experience with LIMS (LabVanatge) 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.
Qualifications:
- Experience level: Experienced
- Education: Bachelors
Skills:
- Computerized System testing
- validation
- HPALM
- SDLC processes
- GxP regulations
- project organizational skills
Overview
Område | Deerfield, IL |
Arbejdsbyrde | 40 Timer / Uge , 100 % onsite |
Forventet startdato | Hurtigst muligt |
Forventet slutdato | Åben |
Nødvendige sprog | Engelsk |
Nødvendige kvalifikationer | IT, Lead, Technical, Validation, system |
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