This role involves owning and maintaining the Quality Management System to ensure alignment with client GMP requirements and Downer standards
Job Summary
This role involves owning and maintaining the Quality Management System to ensure alignment with client GMP requirements and Downer standards.
The successful candidate will plan and coordinate internal audits, client audits, and regulatory inspections while managing deviations and quality events.
Downer offers a high-performance culture with extensive training opportunities, healthcare discounts, and a commitment to diversity and belonging.
Matching Summary
This role involves owning and maintaining the Quality Management System to ensure alignment with client GMP requirements and Downer standards.
Skills & Requirements
Must-have
Extensive pharmaceutical or GMP experience
Quality Management System (QMS) maintenance
GMP, EHS, and regulatory compliance auditing
Deviation and non-conformance management
CAPA implementation and tracking
Training coordination for staff and subcontractors
Nice-to-have
Strong work ethic and positive attitude
Experience with TGA and OGTR regulations
Ability to build client relationships
Commitment to diversity and inclusion
Flexible working arrangements support
Key Requirements
Extensive experience in pharmaceutical or life sciences
Demonstrated experience in quality systems and auditing
Knowledge of TGA and OGTR regulatory expectations
Experience managing onsite operational teams and subcontractors