Breathe Life Sciences (BLS) is a TGA-licensed pharmaceutical manufacturer based in Meadowbrook, Queensland. We operate under Good Manufacturing Practice (GMP) frameworks including PIC/S PE 009.
A full-time position is currently available within the company for an experienced Quality Auditor to join our Quality and Regulatory team. Working closely with cross-functional teams, you will play a crucial role in maintaining the highest standards of quality assurance and compliance across our manufacturing operations.
Key duties of the role:
- Lead internal audits and ensure continual audit readiness in production and warehouse, inspections, and quality management system reviews to ensure ongoing compliance with TGA regulations, GMP guidelines (PIC/S PE 009), and other relevant standards.
- Analyse organisational methods, processes, and workflows across manufacturing and quality functions to identify inefficiencies, non-conformances, and opportunities for improvement.
- Review and audit standard operating procedures (SOPs), batch records, validation protocols, and other GMP documentation for compliance, accuracy, and completeness.
- Perform deviation investigation, root cause analysis, and trending to identify and resolve quality issues, and implement corrective and preventive actions (CAPAs).
- Conduct risk assessments and recommend systemic improvements to enhance product quality, operational efficiency, and regulatory compliance.
- Prepare audit reports, trending analyses, and management review inputs for senior leadership.
- Provide training and guidance to team members on quality systems, regulatory requirements, and best practices in quality assurance.
- Collaborate with manufacturing, research and development, and regulatory affairs teams to support product development, scale-up, and commercialisation activities.
- Maintain and update audit records, documentation, and reports in accordance with regulatory requirements and company policies.
- Uphold a culture of quality and compliance through effective communication, training, and adherence to established standards.
Skills and experience required:
- Bachelor’s degree in Chemistry, Pharmacy, Biotechnology, or related field; advanced degree preferred.
- Minimum of 2 years of experience in quality assurance, quality control, or audit roles within the pharmaceutical, biotechnology, or related regulated industry.
- Strong knowledge of TGA regulations, GMP guidelines, and international quality standards (e.g. ICH, USP, EP).
- Demonstrated experience in conducting internal and external audits, inspections, and regulatory submissions.
- Excellent attention to detail, organisational skills, and the ability to prioritise and manage multiple tasks effectively.
Job Type: Full-time
Pay: $80,000.00 – $90,000.00 per year
Work Location: In person
