Quality & Training Specialist for CRO Growth

Planet Pharma; Melbourne; Sur place; AUD 85 000 - 110 000; Plein temps

Résumé du poste

Planet Pharma in Melbourne, Australia is seeking a Quality & Training Associate to strengthen quality systems, ensure regulatory compliance, and develop workforce capability across the organisation. You will partner with study teams and clients to keep activities inspection-ready and aligned with ICH-GCP and internal SOPs, supporting audits, CAPAs, and continuous improvement.

This role offers long-term career growth in clinical quality, training, and operations within a collaborative CRO

Qualifications

• Experience in CRO/clinical research environment.
• Hands-on quality and compliance activities experience.
• Exposure to QMS, SOPs, CAPAs, deviations, and audits.

Responsabilités

• Support ongoing management and improvement of the Quality Management System (QMS).
• Maintain quality documentation, including SOPs, work instructions, CAPAs, deviations, change controls, and training records.
• Assist with internal and external audits, sponsor assessments, and inspection readiness activities.
• Participate in investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
• Ensure quality documentation remains accurate, current, and compliant.
• Engage in risk assessments and process improvement projects.
• Collaborate with operations to promote a strong quality culture.

Connaissances

ICH-GCP knowledge

Quality & compliance experience

QMS experience

SOPs & CAPAs management

Attention to detail

Stakeholder management

Independent working

Description du poste

Planet Pharma in Melbourne, Australia is seeking a Quality & Training Associate to strengthen quality systems, ensure regulatory compliance, and develop workforce capability across the organisation. You will partner with study teams and clients to keep activities inspection-ready and aligned with ICH-GCP and internal SOPs, supporting audits, CAPAs, and continuous improvement.

This role offers long-term career growth in clinical quality, training, and operations within a collaborative CRO