About this role
Role Overview
- Ensuring GMP compliance and performing Quality Assurance operations
- Establishing, maintaining, and developing QA operations and systems processes
- Collaborating with Global QA BioNTainer Team and AUS Quality organization
- Implementing local GMP standards and quality systems
- Providing support for audits and inspections
- Maintaining GMP compliance and authoring QA procedures
Requirements
- University degree in relevant scientific discipline
- 6-8+ years of relevant experience in pharmaceutical industry GMP/GDP experience
- Working knowledge of relevant regulations and guidelines (TGA, PIC/S, ICH)
- Experience with national or international regulatory agency and participation in inspections
- Quality Operations experience across pharmaceutical GMP functions
- Experience within a quality organization supporting development of IMPs
- Fluency in English (written and spoken) is essential
Benefits
- Competitive remuneration packages determined by specific role and qualifications
- Variety of benefits in support of diverse employee base