At a Glance
- Tasks: Support quality assurance activities and manage product release and complaints.
- Company: Aspen Pharmaceuticals, a leading Australian pharmaceutical company.
- Benefits: Full-time permanent role with competitive salary and career growth.
- Other info: Join a dynamic team focused on compliance and quality in the pharmaceutical industry.
- Why this job: Make a difference in healthcare by ensuring quality medicines reach patients.
- Qualifications: Tertiary qualifications in Science or related field; 2 years QA experience required.
The predicted salary is between 67500 - 82500 $ per year.
Aspen Pharmaceuticals – St Leonards Park NSW
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.
- Strong interpersonal and written and verbal communication skills.
- Excellent attention to detail.
- Sound project management skills preferred.
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Quality Assurance Associate in Sydney employer: Aspen Pharmaceuticals
Aspen Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration. With a strong commitment to employee growth, we provide opportunities for professional development while promoting a healthy work-life balance through our part-time role in Sydney's vibrant North Metro area. Join us to make a meaningful impact in the healthcare sector while being part of a supportive team dedicated to improving community health.
