Position: IT Validation Lead
100% remote work
Duration: 12 months Contract
Can be 100% remote (in US only).
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 XXX's. 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 ValidationPlan 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 rules and processes
- 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 validationtest scripts as assigned, assist with preparing and updating validationdocumentation 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: validationanalysts, assignments, progress, etc.
- Develop and execute system test cases, scripts and plans.
- Understand and follow appropriate SDLC, quality validationprocesses and application processes.
- Familiar and capable of trace matrix generation
- Support IT technical and IT validationteams for the development of the functional specifications and the functional testing
- Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
- Highly skilled in Computerized System testing and validationin 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.