Senior Scientist, CPV, Comparability, and Statistics
APAC, AU, Victoria, Melbourne, CSL Limited Melbourne, Australia
AUD 106K-121K (estimate) Senior-level Full Time
Tasks
- Analyze process data for trends variability drift
- Apply statistical methods SPC DOE regression multivariate analysis
- Define monitor interpret CQAs and CPPs
- Lead CPV program design implementation maintenance
- Partner with MS&T process development manufacturing quality teams
- Perform statistical comparability assessments
- Provide statistical justification for regulatory submissions audits and inspections
- Support investigations deviations and CAPA
Perks/Benefits
- N/A
Skills/Tech-stack
CAPA | Comparability studies | Continued Process Verification | Critical Quality Attributes | Data analytics | Design of Experiments | GMP | JMP | Key Process Parameters | Minitab | Multivariate analysis | Process Verification | Process control | Process parameters | Process validation | Python | Quality attributes | R | Regression Analysis | Regulatory Compliance | Statistical Process Control | Statistics
Education
Roles
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