Quality Assurance Associate

Quality Assurance Associate

Full-time | Malaga, Western Australia

Join a growing pharmaceutical manufacturer

Care Essentials PharmAust is a GMP-licensed pharmaceutical manufacturing company based in Malaga, WA. We manufacture a range of non-sterile pharmaceutical and healthcare products for customers across Australia.

As our manufacturing operations continue to expand, we are seeking an experienced Quality Assurance Associate to join our Quality team.

This is not an entry-level or general administration position. Applicants must have previous quality experience within pharmaceutical manufacturing or a closely related GMP-regulated industry and be confident working with pharmaceutical quality systems and controlled documentation.

About the role

This is a hands-on quality role working closely with QA, QC, Production, Warehouse, and Management.

The successful candidate will support the ongoing operation of PharmAust’s Pharmaceutical Quality System and help ensure our products, processes, and documentation comply with GMP, regulatory, and customer requirements.

You must be organised, confident working with detailed technical documentation, and able to manage quality actions through to completion.

Key responsibilities

• Support the day-to-day operation of PharmAust’s Pharmaceutical Quality System

• Create, review, issue, maintain, and archive controlled documents

• Review batch manufacturing and packaging records for completeness and GMP compliance

• Assist with deviations, CAPAs, change controls, investigations, and product complaints

• Maintain QA registers, logs, training records, and quality-system trackers

• Prepare and review SOPs, specifications, forms, and quality records

• Follow up outstanding quality actions with relevant departments

• Assist with internal audits, customer audits, supplier audits, and regulatory inspections

• Support validation, qualification, and new-product introduction activities

• Assist with supplier and material qualification processes

• Contribute to product quality reviews and quality-data collation

• Promote GMP compliance and good documentation practices throughout the business

• Work collaboratively with Production, QC, Warehouse, and Management to resolve quality matters

Essential experience and qualifications

To be considered for this position, applicants must have:

• Previous experience in a Quality Assurance role within pharmaceutical manufacturing or a closely related GMP-regulated industry

• Practical working knowledge of GMP and good documentation practices

• Experience with controlled documents and pharmaceutical quality records

• Experience reviewing batch manufacturing or packaging records

• Practical exposure to deviations, CAPAs, investigations, and change controls

• Experience supporting GMP, regulatory, or customer audit preparation

• Experience preparing, reviewing, or updating SOPs and quality-system documentation

• Strong document-control and record-management skills

• Excellent attention to detail and a methodical approach to work

• Strong written and verbal communication skills

• The confidence to follow up outstanding actions across different departments

• The ability to manage competing priorities and meet deadlines

• Sound computer skills, including Microsoft Word, Excel, and Outlook

• A qualification in pharmaceutical science, chemistry, microbiology, quality management, or a related discipline

Applicants who do not have relevant GMP quality experience will not be suitable for this position.

What PharmAust offers

• A full-time position with a growing Australian pharmaceutical manufacturer

• Broad exposure to pharmaceutical quality systems and manufacturing operations

• Involvement in new-product, validation, and operational-growth projects

• A supportive and collaborative working environment

• Opportunities to further develop your pharmaceutical QA career

• An on-site position at our Malaga manufacturing facility

How to apply

Please submit your résumé and a brief cover letter clearly outlining your pharmaceutical or GMP quality-assurance experience.

Applicants must have the right to work in Australia.

Please note: This is a full-time, on-site position and is not suitable for remote or work-from-home arrangements. Only applicants with relevant GMP quality experience will be considered.