Quality Assurance Associate – Validation

About the role

Join Sigma Healthcare to lead validation and qualification activities across its distribution centres in Victoria and New South Wales. Reporting to the Quality Manager, you will ensure validation systems are inspection‑ready and aligned with GMP, GWP and regulatory requirements.

Key responsibilities

• Develop, implement and maintain the Validation Master Plan and qualification framework.
• Plan and execute validation and qualification activities for facilities, equipment and warehouse systems, including IQ/OQ/PQ protocols.
• Prepare and review validation documentation such as URS, risk assessments, protocols and reports.
• Support Computerised System Validation (CSV) for GxP systems and data integrity.
• Coordinate temperature‑mapping programmes and investigate temperature excursions.
• Drive change controls, deviations and CAPAs related to validation.
• Assist with internal, customer and regulatory audits and inspections.

Required profile

• Degree in Science or a related discipline.
• Experience in Quality Assurance, Validation or Quality Systems within a regulated environment.
• Strong knowledge of GMP, GWP, GDP and quality management systems.
• Excellent technical writing, analytical skills and attention to detail.
• Ability to work autonomously and collaborate with diverse stakeholders.

Required skills

• Computerised System Validation (CSV) for GxP systems.
• IQ/OQ/PQ protocol development and execution.
• Temperature‑mapping and excursion investigation.
• Risk assessment and validation documentation (URS, validation reports).

What we offer

• Learning and development programmes, including a leadership pathway.
• Annual salary reviews linked to performance.
• Hybrid work model: one day remote per week, four days onsite.
• Paid parental leave (six weeks primary, one week secondary).
• Employee discounts, onsite canteen, shuttle bus service and EAP support.