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Validation SOP QA IT Professional Analyst
(Jobs in SCHAUMBURG, IL)
 
Requirement id 63868
Job title Analyst
Job location in Schaumburg, IL
Skills required Validation, SOP, Risk Analysis, QA IT Professional
Open Date 06-Sep-2017
Close Date
Job type Contract
Duration 4 Months
Compensation DOE
Status requirement ---
Job interview type ---
   Email Recruiter: coolsoft
Job Description Analyst: Validation, SOP, Risk Analysis, QA IT Professional

Start Date : 09/25/2017
End Date : 12/29/2017
Submission Dead Line : 09/12/2017
Description :

Primary Responsibilities:
Authors, coordinates, performs, and assists in the development of computer system life cycle/computer system validation documentation and tasks to establish computerized systems that meet business requirements, regulatory requirements, and industry standards. Computer system life cycle/computer system validation documentation includes, but is not limited to: User Requirement Specifications (URS), Functional Specifications, Design Specifications, Risk-Analysis, Traceability Matrices, SOPs, Installation Qualification (IQ) protocols, Operation Qualification (OQ) protocols, Performance Qualification (PQ) protocols, development of hardware/software test cases, execution of hardware/software testing, Validation Master Plans (VMP), and Final Reports (FR).
Specific Skills and/or knowledge, credentials, or professional certifications:
Prior work experience authoring, executing and coordinating computer systems validations.
Prior work experience authoring, executing and coordinating computer systems change controls.
Prior experiencing working in a GxP environment, specifically with GxP computerized systems.
Prior work experience with FDA regulations 21 CFR Part 11, 210, 211.
Prior work experiencing with GAMP 5 processes (GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems).
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 63868 while calling.
 
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(Analyst: Validation, SOP, Risk Analysis, QA IT Professional in Schaumburg, IL)
     
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