We have an Urgent opening .Please see the Job Description Below and let me
know if you have any consultant available.
*Position: Validation Tester/Lead*
*Location: Chicago, IL *
*Duration: 6 month*
*Technical/Functional Skills *
• Excellent understanding of Quality & Compliance in an IT
• Experience in Information Technology, performing computer
system validation activities, including authoring/review/approval of
computer system validation deliverables, including requirements gathering,
test plans, test scripts/cases, traceability, and summaries.
• Experience in Inspection Readiness and Periodic Review
• Working experience of GxP regulations, 21 CFR part 11
• Exposure to Regulatory inspections including interactions with
auditors and inspectors
• Demonstrated skills for independently guiding quality and
compliance activities during system development and implementation.
*Roles & Responsibilities *
• This individual is responsible for the following functions:
• Interact with Project team and Business Representatives to
understand the scope and purpose of the business process work stream.
• Provide consultancy to IT teams related to quality and
compliance of IT managed projects. This includes providing guidance
(answering questions, addressing compliance issues) on the governing
solution delivery life cycle to the project teams as appropriate.
• Review / approve IT solution life cycle records requiring QA
approval for projects, such as plans, requirements, testing documents,
deviations, and summaries.
• Author documentation as required.
• Initiate or review and approve Compliance Risk Profiles of High
or Medium compliance risk category.
• Ensure that all Regulated Systems are Audit/Inspection ready
*Wasim AhmedUnited Software Group Inc.. 565 Metro Place South. Suite #
110 Dublin, OH 43017 Phone: 614-495-9222 ext 494Fax: 1-866-764-1148
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