Quality Assurance Specialist

1 month ago

Sydney, New South Wales, Australia Icon Group Full time
Pharmaceutical Quality Assurance Role in Sydney

We are seeking a highly skilled Quality Assurance Specialist to join our team in Sydney. As an integral member of our quality team, you will report to the Quality Pharmacist Supervisor and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements.

About the Opportunity

This is a fantastic opportunity to expand your current skill set and support the quality processes we have in place. You will drive ongoing continuous improvement in quality performance across the site and the business, identifying key areas of focus and implementing improvements to raise compliance and efficiency.

Your 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
About Us

We are part of Icon Group, Australia's largest dedicated cancer care provider, with a global presence in Singapore, Mainland China, Hong Kong, and New Zealand. Our vision is to deliver the best care possible, to as many people as possible, as close to home as possible.

About You

To be successful in this role, you will need:

  • Experience in a GMP compliant pharmaceutical manufacturing environment
  • Experienced in a sterile compounding environment
  • Experience with regulators of pharmaceutical manufacture (e.g. 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 or relevant discipline
  • Good communication skills
Salary and Benefits

The salary for this role is approximately $80,000 - $110,000 per year, depending on experience. We also offer a range of benefits, including opportunities for career growth and development, a dynamic and supportive work environment, and a competitive salary package.

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