• Fantastic team and company culture
• Rapidly growing, global organisation
• Mount Kuring-gai Location
• Flexible work arrangements

About the role:

We are currently seeking a Quality Assurance Associate to join our team based in Mount Kuring-gai. Reporting to the Quality Assurance Manager, this is a great opportunity for someone looking to start or grow their career in Quality Assurance within a supportive and collaborative environment. You will assist with key elements of the Company’s Quality Management System and help ensure ongoing compliance with TGA, other regulatory requirements, and Fresenius Kabi global standards.

If you are enthusiastic, eager to learn, and interested in building a career in Quality Assurance, we would love to hear from you.

Key Accountabilities:

• Ensure Fresenius Kabi products distributed within Australia and New Zealand are fit for intended purpose by managing new product introduction, local product re-labelling, managing incoming goods inspections and product quality holds.
• Be a key role in the complaint management process and when required participate in internal audits and lead continuous improvement activities. Furthermore, you will be involved in the management of the electronic Document Management System and review of internal procedures to improve the company’s compliance status.
• You will also assist in managing complaints, change, deviations, CAPA in the electronic Quality Management System, participate in local supplier management activities and process product quality failures.

What we are looking for:

• Bachelor’s Degree in a science or related discipline essential
• Experience in a Quality Assurance role within pharmaceutical or medical device manufacturing environment desirable
• Excellent communication and collaboration skills
• Good understanding of GMP, PIC/S, ISO 9001 essential
• Highly motivated, results driven and goal oriented
• High level computer skills and strong attention to detail

And……Fresenius Kabi values our employees!

As a reward for your commitment and effort, we will provide you with a competitive base salary and an incentive program. In addition to this, we also provide:

• Flexible working environment and arrangements
• A culture focused around personal development and health and wellbeing
• Recharge leave days and Birthday Leave
• Various lifestyle and support programs for our employees, including EAP, study support and reward and recognition programs.

About Fresenius Kabi:

At Fresenius Kabi, we have a singular purpose – Advancing Patient Care. This corporate philosophy allows us to provide the highest-quality medicines and technologies to those in need. Our product portfolio comprises of a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products, as well as the devices for administering these products. In Gastroenterology, we supply market leading products that play an essential role in preparing patients for colonoscopies. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for the collection of blood components and extracorporeal therapies.

We are committed to equal employment opportunity for everyone, regardless of age, gender, ability, race, religion, sexual orientation, or ethnicity. This allows us to be a diverse and inclusive workplace, which promotes understanding and acceptance among our employees and the broader community. We encourage applications from all, including those of Aboriginal or Torres Strait Islander descent. For more information about Fresenius Kabi Australia, please visit our website www.fresenius-kabi.com.au

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