Quality Associate

3 weeks ago

Adelaide, South Australia Icon Group Full time
Overview

Join to apply for the Quality Associate role at Icon Group

Quality and Safety – Adelaide – Full Time – Slade Health (Woodville, SA) – Permanent full-time position. The role reports to the Site Quality Manager and collaborates with Operations to ensure GMP-compliant, high-quality compounded products.

Part of something bigger: Icon Group is Australia's largest dedicated cancer care provider with a global presence. Our culture emphasizes purpose, impact, connection, opportunity and ongoing innovation.

Responsibilities
  • Ensure all incidents, deviations and complaints are reported to the appropriate persons and registered in the QMS in a timely fashion.
  • Conduct investigations and root cause analyses of non-conformances, supplier and customer complaints.
  • Prepare customer complaint responses and monthly reports.
  • Participate in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
  • Conduct training for staff against Quality procedures and requirements; ensure training records are complete.
  • Provide advice and guidance to staff regarding quality processes and procedures as requested.
  • Maintain and organise the site micro laboratory.
  • Coordinate cytotoxic/antibiotic residue monitoring of cleanrooms.
  • Support Environmental Monitoring activities and perform quality assessments of quarantined incoming goods as required.
  • Drive ongoing continuous improvement in Quality performance, identify focus areas and promote a quality culture across the site and business.
About You
  • Experience in a GMP-compliant pharmaceutical manufacturing environment.
  • Experience in a sterile compounding environment (desirable).
  • Experience in development and application of Quality Systems.
  • Experience with regulators of pharmaceutical manufacture (e.g., TGA).
  • Experience in continuous quality improvement.
  • Competency in common IT software (MS Word, MS Excel, MS Visio).
  • Strong project, time and task management.
  • Tertiary qualification in a Science discipline (preferably microbiology or chemistry).

The successful candidate will thrive in a fast-paced environment with strong communication skills and leadership capability.

Additional Information

Pre-employment health requirement applies. Icon Group is committed to managing the risk of transmission of specified vaccine-preventable diseases; some roles may require evidence of vaccination or non-susceptibility.


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