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Title: Quality System Representative (QSR) Location: Vernon Hills, IL Duration: 6+ months Client: CSC Job Description: 1. Responsible for assuring a system/application meets its requirements and is compliant with applicable Baxter QMS documents, and the documentation set outlined in the Validation Plan for the project. 2. Responsible for approving the documents required for the development and validation of the computerized system. a. Approves the Validation Plan, Training Plan, Training Records, Issues Log, Functional Specification, Design Specification, Design Review, User Manuals, System Procedures, IQ Protocols/Reports, OQ Protocols/Reports, PQ Protocols/Reports, Test Cases, Test Incidents, Trace Matrix, System Description, Supplier Audit Report, and Validation Report. b. Contributes to or gathers Quality/Risk metrics for reporting purposes. c. Utilizes HP QC for end to end test management. 3. Supports a CSO in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable, and consistent operation of the computerized system. Also considers non-quality aspects of risk management. a. Complexity – Performs all complexity work activities that champion approved IT validation strategies throughout the functions/regions. Work involves risk-based application of validation approach, and can include multiple projects/systems work simultaneously. 4. May provide direct or indirect leadership to others. a. Guide, mentor and motivate team members to think more broadly related to cross-functional/business risk management. Provide formal performance review feedback for team resources. 5. CAPA Processes a. May be responsible for reviewing and approving that all documentation within a CAPA has met the procedural requirements and CAPA plans 6. Exception Management a. Monitors and reviews exception reports for progress and completeness against procedural requirements. 7. Ability to manage/influence in a globally matrixed environment (Community of Practice) a. Build and maintain relationships across functions throughout a region. 8. Quality Awareness a. Responsible for understanding and communicating Baxter’s Quality Management System structure and process. b. Perform as a champion of QMS processes, initiatives and improvements throughout a region. This position is responsible and accountable for contributions to the quality of project delivery by performing project-applicable Quality Compliance functions in a global environment, and ensuring that the product developed meets the requirements defined. The Regional QSR is responsible for monitoring compliance to the CQPs, Baxter QMS, and other established IT policies/procedures throughout a region. This position will contribute to improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given region of IT. Desired skills / certifications / training 1. Minimum of 7 years experience in a quality systems environment, or equivalent work experience. 2. Excellent analytical and judgment capabilities and communication skills, and the ability to work with both IT management and staff. 3. Experience acting as the Quality Representative and reviewing end to end life cycle documents for enterprise and quality systems like ERP JD Edwards, ArisG, Trackwise, Documentum, LIMS including infrastructure set up and qualification. 4. Experience using Quality Center. 5. Thorough knowledge of applicable procedures, specifications, regulations and standards. 6. Ability to make good judgments and quick decisions. 7. Solid presentation skills. 8. Solid oral and written communication skills and teamwork skills. 9. Strong influencing skills. Healthcare Quality Validation process/procedures exposure *Thanks & Regards* *Sriram,* *Saperedata Technologies | A Pool of Wise Professional* *sri...@saperedata.com* <https://p3plcpnl0094.prod.phx3.secureserver.net:2096/cpsess6587288724/3rdparty/squirrelmail/src/compose.php?send_to=sriram%40saperedata.com> *Direct: 732-429-1833* *Desk:7325268688 Ext: 106* *1433 Oak Tree Road,Level 2* *Iselin,Nj 08830* *Fax #201-508-2996* Note: We respect your Online Privacy. This is not an unsolicited mail. Under Bills.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include Contact information and a method to be removed from our mailing list. 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