Principal Specialist QA Tech Ops
Core
Ensure quality, compliance, and technical excellence of large-scale mRNA manufacturing operations in Australia, covering validation, GMP facility initiatives, and QC laboratory support.
Role type
Principal Specialist QA Tech Ops (Pharmaceutical Quality)
Builds
Inspection-ready manufacturing operations for mRNA medicines
Domain
Biotechnology / mRNA Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical quality oversight, validation lifecycle management, GMP compliance, equipment qualification, process validation, deviation investigation, CAPA management, change control, risk-based decision making, technical writing for GMP documentation, cross-functional partnership
Preferred skills
Sterile drug product manufacturing, process performance qualification (PPQ), continued process verification (CPV), QC laboratory equipment qualification, formal quality risk management methodologies, technology transfer, startup, and commissioning
Technologies
GMP systems, validation protocols, risk assessment tools
Responsibilities
Provide quality oversight for manufacturing operations, technology transfer, and QC laboratory activities; Lead or support quality review of deviations, investigations, CAPAs, and change controls; Review and approve validation documentation and GMP records; Maintain floor presence to ensure GMP compliance; Coach teams on validation principles and risk-based quality expectations; Drive continuous improvement of validation systems and operational readiness.
Seniority
Senior, hands-on IC with strategic oversight