Sr Quality Engineer, Validation

BAXTER HEALTHCARE PTY AUS

**
Prepare and review validation protocols
Coordinate cross-functional validation activities
Monitor qms elements like change control
** 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. **

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

** 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. **

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
  • Knowledge of GMP and regulatory requirements
  • Proficiency with QMS tools like Trackwise

Work Rights

Not specified

Tailored Resume

Cover Letter