Senior Quality Associate (Pharmaceutical)

Location: Melbourne, VIC, Australia

Company

Contract Manufacturing division producing laundry, household cleaning, car care, pest control, edible oils, air care, and pet cleaning products using blending, granulating, and packaging technologies.

What you will do

• Manage and continuously improve the Pharmaceutical Quality System in line with GMP, GXP, TGA, PIC/S, FDA, customer, and corporate requirements.
• Control SOPs, specifications, forms, quality records, and change control processes.
• Lead investigations into deviations, non-conformances, complaints, and audit findings using risk-based decision-making and root cause analysis.
• Develop, implement, and verify CAPA effectiveness and monitor quality KPIs, trends, and metrics.
• Coordinate internal audits, self-inspections, supplier assessments, customer audits, and regulatory inspection readiness.
• Support supplier qualification, batch documentation review, batch disposition, product release, and quality reporting.

Requirements

• Bachelor’s degree in science, pharmacy, chemistry, microbiology, chemical engineering, or a related discipline.
• At least 5 years of Quality Assurance experience in a GMP-regulated pharmaceutical or therapeutic manufacturing environment.
• Strong knowledge of Pharmaceutical Quality Systems and GMP, TGA, PIC/S, and relevant industry requirements.
• Hands-on experience with deviations, CAPAs, change controls, investigations, complaints, and document control.
• Experience supporting customer audits, regulatory inspections, and internal audit programs.
• Strong root cause analysis, risk assessment, communication, organisational, analytical, and stakeholder management skills.

Nice to have

• Experience in a Contract Manufacturing Organisation environment.
• Knowledge of validation and qualification activities.
• Internal Auditor or Lead Auditor qualification.
• Experience analysing quality data and trends.

Culture & Benefits

• Part of a group focused on circular economy, packaging, reuse, and recycling solutions.
• Work within a global manufacturing organisation with more than 6,000 employees and 110 facilities across 15 countries.
• Continuous improvement and technology investment are central to the business.