Senior Quality Associate
On-siteMelbourne, Victoria, Australia
Job Summary
Manage and continuously improve the Pharmaceutical Quality System (PQS) to ensure compliance with GMP, GXP, TGA, PIC/S, FDA, and corporate requirements. Lead investigations into deviations, non-conformances, complaints, and audit findings using risk-based decision-making and root cause analysis methodologies. Develop, implement, monitor, and verify Corrective and Preventive Actions (CAPAs) while maintaining quality documentation including SOPs, specifications, and change control processes. Conduct internal audits, self-inspections, and supplier assessments, ensuring site readiness for customer audits and regulatory inspections. Monitor quality KPIs and trends to support continuous improvement initiatives. This role may act as a delegate for the Quality Manager. We are the largest plastics recycler in Australia and New Zealand, operating 110 manufacturing facilities across 15 countries.
Required Qualifications
- A Bachelor's degree in Science, Pharmacy, Chemistry, Microbiology, Chemical Engineering, or a related discipline
- At least 5 years' experience in Quality Assurance within a GMP-regulated pharmaceutical or therapeutic manufacturing environment
- Strong knowledge of Pharmaceutical Quality Systems and regulatory requirements, including GMP, TGA, PIC/S and relevant industry standards
- Hands-on experience managing quality systems, including deviations, CAPAs, change controls, investigations, complaints and document control
- Experience supporting customer audits, regulatory inspections and internal audit programs
- Sound understanding of root cause analysis, risk assessment and problem-solving methodologies
- Proven ability to review and approve GMP documentation with a high level of accuracy and attention to detail
- Strong communication and stakeholder management skills, with the ability to build effective relationships across all levels of the organisation
- Excellent organisational skills and the ability to manage multiple priorities in a fast-paced manufacturing environment
- A proactive, solutions-focused mindset with strong analytical skills, sound judgement and a commitment to continuous improvement
Desired Qualifications
- Experience working within a Contract Manufacturing Organisation (CMO) environment
- Knowledge of validation and qualification activities
- Internal Auditor or Lead Auditor qualification
- Experience analysing quality data and trends to support decision-making and continuous improvement initiatives
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