*Please submit resumes to sri...@saperedata.com <sri...@saperedata.com>*
Title: Quality System Representative (QSR)
Location: Vernon Hills, IL
Duration: 6+ months
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
4. Experience using Quality Center.
5. Thorough knowledge of applicable procedures, specifications, regulations
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*
*Saperedata Technologies | A Pool of Wise Professional*
*Desk:7325268688 Ext: 106*
*1433 Oak Tree Road,Level 2*
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