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Baxter Healthcare is seeking a Senior Quality Engineer specializing in validation to improve healthcare delivery while adhering to regulatory standards. The role involves preparing and reviewing validation protocols, coordinating with cross-functional teams, and ensuring compliance with quality management systems.
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Job Summary
The role involves preparing, executing, and reviewing protocols for equipment, utility, process validation, cleaning validation, and facility qualification.
Candidates must monitor Quality Management System elements including Change Control, Corrective and Preventive Action, and Out-of-Specification events.
The position requires coordinating with cross-functional teams to ensure timely completion of validation activities and proper closure of documents.
Matching Summary
Match Score: 75
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Baxter Healthcare is seeking a Senior Quality Engineer specializing in validation to improve healthcare delivery while adhering to regulatory standards. The role involves preparing and reviewing validation protocols, coordinating with cross-functional teams, and ensuring compliance with quality management systems.
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Skills & Requirements
Must-have
Prepare and review validation protocols
Coordinate cross-functional validation activities
Monitor QMS elements like Change Control
Execute equipment and process qualification
Compile summary reports for regulatory affairs
Nice-to-have
Experience with Trackwise system
Knowledge of GMP regulatory guidelines
Ability to assist during internal inspections
Strong collaboration and communication skills
Key Requirements
Experience in validation and qualification activities