Quality Systems Associate
2 months ago
**This is where you save and sustain lives**
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
**Position Overview**
- Managing Quality Systems at Toongabbie Plant to ensure compliance with Global Quality Policies/Procedures and applicable Regulatory requirements. The scope of Quality Systems is: Baxter Quality System Implementation Program, Internal Audit, Supplier Quality, Licenses and Certificates, Training and Documentation, Monthly Manufacturing KPI Review, Management Review and Annual Product Review/Conformity Assessment.
**Responsibilities**
- Manage effective implementation of Global Quality Policies/Procedures at Toongabbie Plant.
- Manage an effective Internal Audit program for Toongabbie Plant per ANZQCM09 Manual, to meet Local and Corporate Quality Assurance requirements: Ensure each audit is properly scheduled, planned, followed up and closed as per Corporate Quality Policy and Local Regulatory requirement. Coordinate the provision of a pool of qualified lead and second auditors so as to resource the audit program requirements. 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: Process document changes in TcU. Manage document review program per regulatory/Global Quality Policy/Procedure. Assist in artwork creation and maintenance.
- 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.
**Requirements**:
- Tertiary education in Pharmacy, Science, Engineering or equivalent
- Previous experience in Sterile Manufacturing and/or Quality Assurance processes.
- GMP knowledge, strong technical writing ability
- Familiar with Microsoft Suite
**Reasonable Accommodations**
**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.
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