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 managetheChangeControlandCalibrationsystems, ensuring compliance withGlobalQualityPolicies/ProceduresandRegulatoryrequirements. You will drive engagement and development within the ValidationandCalibration team to achieve flawless execution of our objectives.
Responsibilities
1. Collaborate with project managers to build and maintain project plans, ensuring the timelycompletionof validation deliverables
2. Manage the Validation program to meet GlobalQualityPolicies/Proceduresandapplicableregulatoryrequirements
3. Ensure critical systems requirements/procedures align with validation outcomes and are accurately maintained
4. Ownandmanagethe Critical Work Order system to ensure adherence to critical system requirements/procedures
5. Act as theChangeControl Administrator and Trainer for the TW8 system, coordinating all aspects of theChangeControl process
6. Prepare Weekly and Monthly Change control data for management review.
7. Track change controls to meet Global metrics.
8. Responsible for the writing and reviewing of all Validation Protocols, Reports, and Qualification phases – DQ, IQ, OQ, PQ, ensuring compliance withGlobalQualityPolicies/Proceduresandapplicableregulatoryrequirements
9. Manage and coordinate validation qualification activities and deliverables
10. Implement and integrate the Risk Assessment process into validation activities
11. Coordinate the validation review and revalidation/verification activities, ensuring they are completed per requirements
12. Facilitate the review and approval of validation package documents (User Requirements Specification, Functional Specification, Design Specification, etc.)
13. Maintain Validation documentation, including hard & soft copy archives and electronic databases
14. Keep the Validation Master Plan up-to-date inrealtime.
15. Conduct gap analyses and manage actions to align local requirements withGlobalQualityPolicies/ProceduresandRegulatoryrequirements
16. Ensure timelycompletionof calibrations following local procedures, GlobalQualityPolicies/Procedures, and Regulatory requirements
17. Ownandmanagethe Calibration Management systems to ensure continuous improvement and compliance with computerized system requirements
18. Provideexpertise and mentorship on calibration requirements and execution to Calibration Technicians
* ManageValidationandCalibrationsystems within the given budget/Capital Expenditure.
Key Requirements
* Tertiary degree in Electrical / Mechanical / Chemical Engineering orequivalent fields
* Experience working in a validation team within a multinational Pharmaceutical company
* Knowledge of validationandcalibration methodologies, including computerized system validation
* Demonstrated application of GMP in a pharmaceutical manufacturing environment
* Demonstratedability in project management
* Proficiencyin 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 teamenvironment
* A great teammate with a high level of initiative and energy.
Why Baxter?
At Baxter ANZ, we are focusedon being a Best Place to Work where our people can be their authentic self, feel valued and respected. Wearecommitted to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxterand we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to newideas and perspectives. Baxterisan 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.
Baxterisanequalopportunity 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.
Recruitment Fraud Notice
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P O Box 88, One Baxter Drive|Old Toongabbie NSW 2146|Australia
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