- Location
- AU/TON3 - AUS/Old Toongabbie Sales/Mktg, Australia
- Type
- Full-time
- Closing date
- Today
- Source
- Workday
Description
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.
The Role
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!
Key Responsibilities
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 outcomes
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)
Project management experience is highly regarded
Highly developed interpersonal effectiveness and relationship-building abilities
Collaborative approach and ability to work well with others. \
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Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
