Located in the northern suburbs of Victoria, this fast-growing pharmaceutical company is dedicated to delivering high-quality healthcare solutions through innovation and excellence. With the recent addition of new facilities and the integration of leading-edge technology, the company is expanding its capacity to meet industry demands while setting new standards in quality and compliance. As the company grows, it remains focused on fostering a collaborative and supportive environment, providing every team member with the opportunity to make a meaningful impact.
About the Role
As the Quality Assurance Officer, you will be responsible for maintaining and implementing their quality management system, ensuring adherence to industry standards and compliance with TGA regulations. You will report into the Quality Manager and work closely alongside them to ensure that all quality systems, processes, and standards align with regulatory requirements and drive continuous improvement in their operations.
Key Responsibilities
- Oversee and maintain the Quality Management System to comply with TGA and other regulatory standards.
- Assist in audits, including TGA Audits, and collaborate with regulatory bodies to ensure ongoing compliance.
- Identify and implement improvements in quality processes to enhance efficiency and effectiveness.
- Apply strong decision-making and analytical skills to diagnose and resolve quality issues.
- Work collaboratively with internal teams and external stakeholders to promote a culture of quality and continuous improvement.
- Minimum 2-3 years of experience in a quality-focused role within a manufacturing, pharmaceutical, healthcare, or other highly regulated industry.
- Proficiency in Quality Management System requirements, with experience in ISO9001, ISO13485, or similar standards.
- Proven ability to assist in TGA audits and maintain compliance with regulatory standards.
- Excellent communication skills, with the ability to influence stakeholders at all levels.
- Detail-oriented, with strong attention to detail
- A collaborative approach and adaptability to thrive in a fast-paced, dynamic environment.
If you are passionate about driving quality, compliance and excellence, we’d love to hear from you. Please Apply below or reach out to Emily Hammond at Ehammond@sharpandcarter.com.au.