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.
• Robust interpersonal and written and verbal communication skills.
• Excellent attention to detail.
• Sound project management skills preferred.

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