Quality Systems Lead

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.

The Role

As the ANZ-Quality Systems Lead, you will have the outstanding opportunity to manage and lead our Validation team, supporting the Toongabbie Manufacturing Plant in various projects. Your role will be crucial in maintaining the validated states of our Facilities, Utilities, Equipment, Process Computerised Systems, Analytical Methods, and Equipment Cleaning. Additionally, you will manage the Change Control and Calibration systems, ensuring compliance with Global Quality Policies/Procedures and Regulatory requirements. You will drive engagement and development within the Validation and Calibration team to achieve flawless execution of our objectives.

Responsibilities

Collaborate with project managers to build and maintain project plans, ensuring the timely completion of validation deliverables

Manage the Validation program to meet Global Quality Policies/Procedures and applicable regulatory requirements

Ensure critical systems requirements/procedures align with validation outcomes and are accurately maintained

Own and manage the Critical Work Order system to ensure adherence to critical system requirements/procedures

Act as the Change Control Administrator and Trainer for the TW8 system, coordinating all aspects of the Change Control process

Prepare Weekly and Monthly Change control data for management review.

Track change controls to meet Global metrics.

Responsible for the writing and reviewing of all Validation Protocols, Reports, and Qualification phases – DQ, IQ, OQ, PQ, ensuring compliance with Global Quality Policies/Procedures and applicable regulatory requirements

Manage and coordinate validation qualification activities and deliverables

Implement and integrate the Risk Assessment process into validation activities

Coordinate the validation review and revalidation/verification activities, ensuring they are completed per requirements

Facilitate the review and approval of validation package documents (User Requirements Specification, Functional Specification, Design Specification, etc.)

Maintain Validation documentation, including hard soft copy archives and electronic databases

Keep the Validation Master Plan up-to-date in real time.

Conduct gap analyses and manage actions to align local requirements with Global Quality Policies/Procedures and Regulatory requirements

Ensure timely completion of calibrations following local procedures, Global Quality Policies/Procedures, and Regulatory requirements

Own and manage the Calibration Management systems to ensure continuous improvement and compliance with computerized system requirements

Provide expertise and mentorship on calibration requirements and execution to Calibration Technicians

Manage Validation and Calibration systems within the given budget/Capital Expenditure.

Key Requirements

Tertiary degree in Electrical / Mechanical / Chemical Engineering or equivalent fields

Experience working in a validation team within a multinational Pharmaceutical company

Knowledge of validation and calibration methodologies, including computerized system validation

Demonstrated application of GMP in a pharmaceutical manufacturing environment

Demonstrated ability in project management

Proficiency in statistical analysis of data (i.e., Minitab, Tableau, SQL)

Precision and accuracy in documentation and data logging

Highly developed verbal and written communication skills

Strong negotiation skills with the ability to operate in a team environment

A great teammate with a high level of initiative and energy.

Why Baxter?

At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.

Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.

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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. Read more