QARA Specialist

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

We have an exciting opportunity for   a QARA   Specialist to join our   QARA   team at Baxter. Reporting to the   Head of QARA –   ANZ,   you will work collaboratively with the Operations,   Quality,   Regulatory   and Supply Chain teams, enabling   the   timely delivery of fully compliant products and processes   in line   with   the ANZ Commercial Business Plan.   With a   primary   focus on   Quality, this   quality   role will   support   the   effective management of   Quality Management   System,   with particular emphasis on the   documentation   including   management   system and   training.   You will help ensure quality documents, records and training activities are maintained accurately, completed on time and aligned with applicable regulatory and business requirements. In addition, you will assist the QARA team with other quality activities as needed, including CAPA, internal and external audits, Field Actions (FAs),   complaints, nonconforming products,   supplier controls   and other quality processes that support compliance and continuous improvement .     If you are a   passionate   quality   professional looking to make a   meaningful   impact on   patients’   lives, we’d love to hear from you!

Manage   and support Quality Management System   activities , with a key focus on documentation management and training management   with minimal supervision   Maintain, update and control quality documentation, including procedures, forms, records and related quality documents, ensuring accuracy, version control, timely review and compliance with applicable requirements   Coordinate training management activities, including training   assignments , completion tracking, record maintenance and follow-up with stakeholders to support timely and compliant training outcom es   Support document lifecycle processes, including document creation, review, approval, effective release, periodic review, archival and retrieval, in line with internal procedures   and systems   Partner with cross-functional teams to promote compliant documentation and training practices and provide guidance on quality process requirements where required.    Assist   QARA   team   members   with   other   operation   Quality   activities as needed ,   including   CAPA, internal and external audits, Field Actions (FAs),   complaints, nonconforming products,   management reviews,   Field Actions (FAs ),   quality records control,   supplier controls   and other activities required   to maintain   compliance with   ISO 9001   and applicable quality system requirements   Act as a   point of   contact for   enquiries relating   to   documentation and training management . Key Requirements   Tertiary degree in Science or related fields   5   or more   years’   experience working in   a   Quality   environment within the   medical   devices /Pharma   industry is desirable   Good understanding and working knowledge of Australian ,   New Zealand   and European Union   Quality   regulations   (e.g. PICs, EudraLex , other GMP regulations)