BAXTER

Quality Systems Associate

Old Toongabbie, New South Wales Full time

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

At Baxter Healthcare, we uphold the highest standards of quality and excellence in healthcare. We are hiring a professional to take on the Quality Systems Associate role in our Manufacturing Quality team located at our Old Toongabbie site. As a Quality Systems Associate, you will play a crucial role in managing effective implementation of the company’s international quality guidelines and protocols at Toongabbie Plant.

Reporting to the Quality Systems Senior Manager, you will manage an effective internal audit program as per ANZQCM09 Manual, to meet Local and Corporate Quality Assurance requirements. You will work to ensure each audit is properly scheduled, planned, followed up and closed as per Corporate Quality Policy and Local Regulatory requirement.

This is an outstanding opportunity to work with a team that's dedicated to flawless execution and continuous improvement.

Responsibilities

  • Perform internal audits per schedule

  • Support Corporate and Regulatory audits of Toongabbie Plant, including preparation activities, coordinating responses, commitment tracking, reporting and closure

  • Ensure implementation of Supplier Quality requirements per Global Quality Policies/Procedures and ANZQCM24 Manual

  • Ensure all new suppliers are properly reviewed and approved. Manage Supplier Corrective Actions Reports and Baxter Inter Company Non-conformance Systems

  • Maintain Supplier Re-evaluation Process including performing Supplier Audits

  • Organize renewal of Licences for Toongabbie Plant

  • Manage quality system documents for Toongabbie Plant

  • Manage and maintain training matrix and assignment for QA team

  • Assist QA Supervisors and Managers in maintaining Job Descriptions

  • Peform Monthly Manufacturing KPI Review, Management Review, and Annual Product Review/Conformity Assessment per Global and Local procedures

  • Other duties as required.

Key Requirements

  • A Tertiary degree in Pharmacy, Science, Engineering or related fields

  • Proven experience in Sterile Manufacturing and/or Quality Assurance processes

  • Strong understanding of regulatory requirements and quality standards

  • Outstanding attention to detail and analytical skills

  • Excellent communication and teamwork abilities

  • Proficiency in quality management software and tools

  • Ability to strictly adhere to deadlines and manage multiple tasks simultaneously

  • Outstanding communication and collaboration skills.

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

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