Aspen Australia is one of Australia's leading pharmaceutical companies and part of an Asia Pacific-focused pharmaceutical organisation, with offices across Southeast Asia. We have built a portfolio of iconic prescription and OTC brands and are market leaders in many categories. We’re a business inspired to make a difference to individual lives by providing quality, affordable medicines and healthcare products to patients across Australia and the broader region.

We are currently recruiting for a QA Associate to join our Strategic Technical Affairs team based at our Head Office in St Leonards. This is a full-time, permanent position.

Reporting to the Quality Manager, this role is responsible for supporting quality assurance activities to ensure Aspen products meet applicable quality, regulatory and company requirements, with a particular focus on product release and distribution, compliance risk assessments and Product Quality Complaints.

Key Responsibilities

- Manage product release and distribution activities, including review and approval of batch documentation and release of products to market.
- Manage Product Quality Complaints (PQCs), including assessment, investigation coordination,



customer communication, adverse event reporting, escalation of safety information and complaint closure.
- Coordinate residual solvent, elemental impurity and nitrosamine risk assessments, ensuring assessments remain current and compliant with regulatory expectations.
- Coordinate and review Product Quality Reviews (PQRs).
- Review stability data, reports and trends to support product quality, lifecycle management and regulatory commitments.
- Support artwork review and coordination as required.
- Initiate, review and maintain quality system documentation, including SOPs, work instructions and associated records.

What we are looking for

- Tertiary qualifications in Science, Pharmacy, Life Sciences or a related discipline.
- Previous experience (min 2 years) in a QA role within the pharmaceutical, healthcare or medical device industry.
- Sound understanding of GMP, GDP and PIC/S requirements.
- Solid interpersonal and written and verbal communication skills.
- Excellent attention to detail.
- Sound project management skills preferred.

📌 Quality Assurance Associate (Sydney)
🏢 Aspen Pharma Australia
📍 Sydney