Quality Assurance Associate

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 seeking an enthusiastic and detail-oriented 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, you will be responsible for ensuring quality assurance activities are effectively managed to support the quality, safety and compliance of Aspen products. This role plays a key part in managing Product Quality Complaints (PQCs), supporting product release activities and maintaining compliance with applicable quality and regulatory requirements.
Key ResponsibilitiesManage Product Quality Complaints (PQCs) from receipt through to investigation and closure.Coordinate complaint sample returns and arrange product replacement or credits where required.Respond to customer quality concerns and communicate investigation outcomes.Conduct initial risk assessments and liaise with manufacturing sites to support investigations.Manage Safety Reports associated with PQCs, including Safety Information and Adverse Events.Maintain residual solvent, elemental impurity and nitrosamine assessments in line with ICH requirements.Support product release for distribution and quality documentation reviews.Conduct Annual Product Quality Reviews and review stability data.Maintain Quality SOPs and quality system documentation.
What we are looking for:Tertiary qualifications in Science, Pharmacy, Life Sciences or a related discipline.Previous experience in a QA role within the pharmaceutical, healthcare or medical device industry (experience managing PQCs will be highly regarded)Sound understanding of GMP, GDP, PIC/S and TGA regulatory requirements.Excellent attention to detail and proven organisational and time management skills.Strong communication (both verbal and written) and relationship building skills to engage stakeholders and develop the best outcome for our customers and business.Sound project management and problem-solving skills.Proficiency in written documentation and report preparation.