Benefits
- 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, PQRsand 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.
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Senior Quality Associate in Sydney employer: HPG
HPG is a leading global healthcare organisation that prioritises employee wellbeing and safety while driving meaningful change in workplace health initiatives. The company fosters a collaborative environment, offering opportunities for professional growth and exposure to senior leadership roles.
