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.
Join our outstanding team at Baxter Healthcare as the Chemistry Laboratory and Stability Program Lead . This exceptional opportunity allows you to lead a world-class chemistry laboratory and stability program, ensuring the highest quality standards in our manufacturing processes.
Reporting to the Site Quality Head, you will lead a team of Analysts ensure all testing and review of results (including stability studies) are completed as per production schedule, following validated methods/approved procedures. You will guide your team on good laboratory practices, chemical product testing, process control and validation, continuous improvement and projects.

KEY REQUIREMENTS

• Tertiary degree in Science, Chemistry, Environmental Science or related fields
• Prior experience with leadership within a Lab based envionrment
• Experience with Laboratory Information Management Systems (LIMS)
• In-depth experience in the application of process improvement in a Quality management environment
• Demonstrated application of GMP in a pharmaceutical manufacturing environment
• Experience with Trackwise 8 program is desirable
• Demonstrated ability in validation of equipment and methods relating to laboratory testing
• Effective communication skills
• Proven skills in quality control in a sterile manufacturing environment is required
• Demonstrated ability in validation of equipment and methods relating to laboratory testing
• Analytical skills for investigating issues and analyzing trends
• Excellent skills in Microsoft Excel and Word
• Negotiation and influence skills, with the ability to operate in a team environment.

• Approve or reject, upon testing completion and acceptable results, starting materials, packaging materials, intermediate, bulk and finished products
• Ensure that all necessary testing is carried out and the associated records evaluated
• Approve/authorize specifications, sampling instructions, test methods, and other Quality Control procedures in Chemistry Laboratory
• Approve and monitor any contract analysis used by Chemistry Laboratory
• Ensure the qualification and maintenance of the department, premises, and equipment
• Ensure that appropriate validations are done prior to using any equipment or test method as required
• Ensure that the required initial and continuing training of department personnel is carried out and adapted according to need
• Ensure materials are received from approved suppliers
• Designate and monitor storage conditions for reagents and standards
• Retain records following local Regulatory and Baxter Global Quality requirements
• Monitor compliance with Good Manufacturing Practice requirements
• Ensure inspection, investigation, and sampling processes are in place to monitor factors affecting product quality.
• Maintain a timely and effective communication process to address customer concerns and raise quality issues to the appropriate levels of management
• Complete all Chemistry laboratory investigations, including CWO’S, MPI’S, and NCR’S, on time and in accordance with ANZQCM06 and relevant GQO requirements
• Ensure all Chemistry laboratory calibrations are completed per schedule
• Drive EMS and continuous improvement within the Chemistry laboratory
• Engage in monthly reviews that assess process performance, product quality, and the Pharmaceutical Quality system, promoting continuous improvement
• Ensure BaxLIMS is set up for all testing performed in Chemistry Laboratory
• Maintain the Stability Study Program, ensuring product ranges per ANZPDM manual are covered.