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Senior Quality Associate

Contract Manufacturing
Melbourne VIC

Quick Apply

Job Details

Full-time
5 days ago

Qualifications

Analysis skills
Quality assurance
Bachelor's degree
Release management
Organisational skills
Pharmacy
Manufacturing
Document management
Business
Communication skills
Internal audits

Full Job Description

Company Description

Pact's Contract Manufacturing division manufactures across laundry, household cleaning, car care, pest control, edible oils, air care and pet cleaning categories.

Our uniquely flexible and purpose-built facilities utilise the latest blending, granulating and packaging technologies, allowing us to maintain the fastest project completion times in the industry.

Our extensive and proactive research and development capabilities together with our substantial investment in technology and innovation mean we can provide lower manufacturing costs and get our customer’s products on supermarket shelves faster than our competitors.

Job Description

About this opportunity

The Senior Quality Associate is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with GMP requirements, regulatory obligations, customer expectations, and internal quality standards.

Working closely with the Quality Manager and other departments, the role supports the management of quality systems, including deviations, CAPAs, change controls, customer complaints, supplier quality and validation activities, audits, training, and inspection readiness. The position also contributes to continuous improvement initiatives and helps to promote a proactive quality culture across the business.

The Senior Quality Associate collaborates with internal teams, customers, suppliers, and regulatory authorities to support product quality, patient safety, and ongoing compliance. When required, the role may act as a delegate for the Quality Manager, supporting day-to-day quality activities and ensuring continuity of quality operations.

Your key responsibilities will be to:

Manage and continuously improve the Pharmaceutical Quality System (PQS), ensuring compliance with GMP, GXP, TGA, PIC/S, FDA, customer, and corporate requirements.
Maintain and control quality documentation, including 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 methodologies.
Develop, implement, monitor, and verify the effectiveness of Corrective and Preventive Actions (CAPAs) to drive sustainable quality improvements.
Monitor quality KPIs, trends, and metrics, providing insights and recommendations to support continuous improvement initiatives.
Conduct and coordinate internal audits, self-inspections, supplier assessments, and audit remediation activities, ensuring actions are closed out effectively.
Support customer audits and regulatory inspections, maintaining a high level of site inspection readiness at all times.
Participate in quality risk assessments and support the implementation of risk-based approaches to reduce compliance and operational risks.
Support supplier qualification and approval activities, including the review of supplier documentation, quality agreements, and ongoing performance.
Review batch documentation and support batch disposition, product release activities, and management reporting where required.

Your skills and experience

To be successful in this role, you’ll have:

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.

Desirable

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.

Additional Information

About us

Our vision is to lead the circular economy through packaging, reuse and recycling solutions. It’s a future-driven group commitment, designed to create lasting value.

We’re the largest plastics recycler in Australia and New Zealand and one of the region’s biggest user of recycled materials. We have 6,000+ team members, operate 110 manufacturing facilities across 15 countries, and our customers include some of the world’s largest brands that consumers know and trust.

As a global leader in circular and sustainable packaging solutions, we’ve committed to lead the circular economy through a $500 million investment plan.

For us, it’s about finding new and better ways of doing things. Ways to grow business, to give back to the environment and to enrich people’s lives every day.

Our promise is to create a better and more prosperous world all round.

That’s our future Pact. Let’s lead the way together.

Quick Apply

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