Senior Quality Advisor, R&D
Job Type: Full time
CSL has an exciting opportunity for a Senior Quality Advisor, Batch Release to join R&D team at our Melbourne office.
Reporting to the R&D Batch Release and Audit Manager, you will review batch documentation for R&D Intermediates to meet the R&D product technical release timelines for use in clinical studies sponsored by CSL or collaborators.
- Review GMP and non-GMP batch documentation for technical release
- Review batch documentation for systems checks
- Liaise with R&D departments regarding quality related issues with batch documentation and associated deviations, change controls and out of specifications
- Manage R&D change controls, deviations, observations and out of specifications
- Conduct Self Inspections, provide reports promptly, assess inspection responses and provide quality advice to maintain regulatory compliance and continuous improvement
- Perform relevant change control tasks
- Participate in updating of QA documents as relevant to R&D, Market meetings for relevant R&D departments and Product Development Expert Team (PDET) meetings as required
- Mentor and Coach R&D Quality Associates
Your Skills and Experience
- Degree in a relevant Biological Science
- 5+ years of experience in Quality, QC Testing, Regulatory Affairs, Quality Assurance
- Understanding of GMP requirements in the pharmaceutical industry and previous production, Quality or R&D experience within the pharmaceutical industry
- Excellent Interpersonal, negotiation and influencing skills
- Relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL
- Stakeholder relationship and management
How to Apply
Please submit your application by Wednesday 07 June 2023.
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CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.
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