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Quality Compliance Specialist

1 month ago

Brisbane, Queensland, Australia Slade Health Full time
About Us

At Slade Health, we are a national sterile compounding service provider with TGA accredited manufacturing facilities based in Victoria, Queensland, New South Wales, South Australia and New Zealand.

We have been producing aseptically compounded pharmaceutical products such as chemotherapy drugs for use by patients in hospitals for over 50 years.

Job Description

This is an exciting opportunity to join our Quality team as a Quality Compliance Specialist. As an integral member of the team, you will report to the Quality Pharmacist Supervisor and site Quality Manager and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements.

You will play a key role in ensuring quality compliant operations are maintained at all sites. This is a fantastic opportunity to expand your current skill set and support the Quality processes we have in place.

Key Responsibilities:
  • Releasing of compounded batches.
  • Participating in investigation and root cause analysis of non-conformances, supplier and customer complaints.
  • Participating in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
  • Liaising with relevant stakeholders to complete action items related to the above.
  • Conducting and coordinating training on Quality procedures and requirements.

In addition, you may support the team with Environmental Monitoring activities and perform quality assessments quarantined incoming goods as required.

Requirements
  • Experience in a GMP compliant pharmaceutical manufacturing environment.
  • Experienced in a sterile compounding environment.
  • Experience with regulators of pharmaceutical manufacture (eg TGA) desired.
  • Experience in continuous quality improvement.
  • Competency in common IT software (MS Word, MS Excel, MS Visio).
  • Competent in time and task management.
  • Tertiary qualification in a Science discipline.
What We Offer

A competitive salary of $90,000 per annum, plus benefits including professional development opportunities and a supportive work environment.