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.
Responsibilities
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.
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.
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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Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.
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