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Validation Lead-Chicago, IL
Job in
Chicago, Cook County, Illinois, 60601, USA
Listed on 2026-07-15
Listing for:
Georgia IT, Inc.
Full Time
position Listed on 2026-07-15
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Engineering
Regulatory Compliance Specialist
Job Description & How to Apply Below
Validation Lead
Location:
Chicago, IL Rate: DOE $/Yr. Position Type:
Full Time Interview Process:
Phone Followed by F2F US Citizen, Green Card and GC EAD
Technical/Functional
Skills:
- Expert knowledge of and experience with regulatory agency regulations such as FDA GLPs, predicate rules, and 21 CFR Part 11
- Experience in assessing the validation strategy of IT and infrastructures based on the defined SOP's
- Proven track record of leading the timely completion of computer system validations.
- Extensive experience authoring computer system compliance risk validation materials in accordance with FDA GxP regulations, and 21 CFR Part 11 guidelines
- Hands on experience in using Test management tools like Client ALM/QC
- Experience in working in Global Delivery model
- Good co-ordination skills
- Excellent communication
Accountable/Responsible for leading the regulatory compliance team from onsite. These responsibilities will span:
- Project Plan
- Contribution to Data Privacy Plan
- Contribution to FRS, Requirement Analysis
- Contribution to Integrated Risk Assessment
- Identification Of Supporting System Documentation (ISSD)
- Validation Plan
- Test Plan
- Access to Systems and Data
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