Validation Specialist – rfxcel

Description IT Validation Specialist -Collaborate with the information systems team to define needs and achievable solutions andor justifications to system requirements -Perform IT computer system validation on equipment and systems -Translate system requirement specifications into executable validation protocols -Create andor review computer system validation test scripts, validation schedules, risk assessments, requirement specifications, protocols and reports, traceability matrices, and validation summary reports according to the timelines in the project plan.

-Review applicable procedures and system training manuals as applicable.

Participate in project team meeting -Document requirements for business requirements, system security, user roles, workflows, data flows, GxP requirements and how these systems fit into the larger IT infrastructure -Provide support to executors of the protocols when needed -Write reports summarizing system validation activities -Work with IT and User Groups to (a) evaluate change control requests, (b) assess regulatory risk associated with such requests and (c) determine the corresponding validation requirements for such changes -Follow the necessary requirements to maintain the Validated status of the Computerized System.

-Create SOP’s for IT Systems Requirements ExperienceTechnical Skills -2
– 3 years’ experience writing CSV test scripts, protocols and summary reports -Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.

-21CFR11, Data Integrity Guidance, Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements -Sufficiently knowledgeable of FDAEU Regulatory Requirements and industry best practices for computerized system validation to complete tasks -Understands lifecycle approach as well as risk based approach to validation -Experienced with Software development life cycle -Principles and practices of computer compliance, validation and qualification -Generally familiar with GXP regulations particularly in the GCP and Quality areas -Able to work both independently and as a member of a cross-functional project team -Microsoft products such as Word, Excel, Project, and Visio.

-Familiar with Information Technology principles, functionalities and capabilities of computer systems and how computer systems relate to and integrate with larger corporate IT infrastructures -Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures andor techniques for resolution.

-Managing multiple projects, duties and tasks -Communicating clearly and concisely, both orally and in writing.

-Establishing and maintaining effective working relationships with those contacted in the course of work.

-Able to work both independently and as a member of a cross-functional project team -Good written and oral communication skills -Good problem-solving skills -Experience with RF Smart OR RF Excel is required for one candidate Robert Half Technology matches IT professionals with some of the best companies on a temporary, project or full-time basis.

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