Job Description
Full job description
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.
