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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Ensuring continuous compliance of the Compounding Unit with cGMP, “Specials” manufacturing requirements, local procedures, and Baxter Corporate policies
Leading and executing high‑quality documentation reviews with strong technical writing accuracy
Analysing complaint data, monitoring trends, and managing CAPAs to drive effective solutions
Supporting thorough, timely investigations for deviations, complaints, and non‑conformances
Ensuring all Quality System and GMP commitments are completed within required timelines
Supporting preparation and development of Annual Product Quality Reviews, including data collation and analysis
Contributing to validation activities and change control processes
Proactively identifying continuous improvement opportunities within Quality Systems, QA, and Operations
Communicating significant GMP or product quality issues to QA Management promptly
Ensuring full compliance with EHS, GMP, GDP, corporate policies, and external regulatory requirements
Conducting and participating in Gemba activities, identifying compliance gaps and supporting implementation of corrective actions
Requirements:
Experience in a GMP or regulated manufacturing environment (pharmaceutical experience idea but not essentiall)
Confidence in reviewing complex data sets and producing accurate, high‑quality reports
Excellent attention to detail and a proactive approach to identifying issues and improvements
Strong communication skills and the ability to challenge appropriately in support of compliance
A collaborative mindset with the ability to work effectively with Operations, Quality Systems, and wider teams