At a Glance
- Tasks: Drive quality improvements and implement new processes in a supportive team.
- Company: Global healthcare organisation committed to quality and innovation.
- Benefits: Hybrid work model, collaborative environment, and opportunities for professional growth.
- Other info: Join a close-knit team that values accountability and continuous improvement.
- Why this job: Make a real impact in quality assurance within the healthcare sector.
- Qualifications: Tertiary qualification in Science or related field with 3 years of QA experience.
The predicted salary is between 75600 - 92400 $ per year.
Health and Aged Care Professionals – Sydney NSW
Contract Hybrid
Hybrid working arrangements, 2 days in the office.
Opportunity to drive Quality improvements and implement new processes.
Collaborative and supportive team environment.
About the company
Our client is a well-established global healthcare organisation with a diverse portfolio of trusted healthcare products. With a strong commitment to quality, innovation and continuous improvement, the business operates across international markets and works closely with external manufacturing partners.
About the opportunity
An exciting opportunity has become available for a Senior Quality Assurance Associate to join a collaborative Quality team. Reporting to the Quality Manager, this is a hands-on role supporting GMP compliance, contract manufacturing oversight and Quality improvement initiatives across the Australian business. Working within a supportive team, you will have the opportunity to take ownership of Quality activities, strengthen relationships with external manufacturing partners and support the implementation of local processes aligned with Australian regulatory requirements. This role would suit a proactive Quality professional who enjoys combining technical expertise with stakeholder engagement, training and continuous improvement.
Duties:
- Support Quality oversight and compliance activities across external contract manufacturing partners.
- Conduct and support Quality investigations, non-conformances and CAPA management.
- Coordinate and support validation activities to ensure compliance with GMP and regulatory requirements.
- Support stability programs, PQRs and broader manufacturing Quality activities.
- Review, develop and implement Quality procedures aligned with Australian TGA requirements.
- Identify opportunities to streamline processes and strengthen local Quality systems.
- Work closely with contract manufacturers to establish clear Quality expectations and drive continuous improvement.
- Develop and deliver Quality training, workshops and educational initiatives across the business.
- Partner with Regulatory Affairs, Commercial and Operations teams to support Quality compliance and implementation activities.
Skills and Experience:
- Tertiary qualification in Science, Pharmacy or a related discipline.
- 3 years' experience in Quality Assurance within pharmaceuticals, medical devices or a related regulated industry.
- Strong understanding of GMP and Australian TGA regulatory requirements.
- Experience working with or overseeing external contract manufacturers highly regarded.
- Hands-on experience in Quality investigations, CAPA and validation activities.
- Experience developing, reviewing or implementing SOPs and Quality processes.
- Strong communication and stakeholder engagement skills, with the ability to translate complex Quality requirements into practical guidance.
- Proactive, organised and confident taking ownership of competing priorities.
Culture:
Join a close-knit, collaborative team that values openness, accountability and continuous improvement.
Senior Quality Associate in Sydney employer: Health and Aged Care Professionals
Join a leading Australian business in the therapeutic goods sector, where you will play a pivotal role as a Regulatory and Quality Manager in Melbourne. With a strong focus on employee development, a collaborative work culture, and the opportunity to shape compliance processes, this position offers a rewarding environment for those looking to make a significant impact. Enjoy competitive remuneration, a supportive team atmosphere, and the chance to work closely with senior leadership and international suppliers, all while contributing to the health and safety of the community.
Contact Details:
Health and Aged Care Professionals Recruitment Team
