Pharmaceutical Quality Control Specialist

11 hours ago

Sydney, New South Wales, Australia beBeeContinuousImprovement Full time $100,000 - $120,000
Quality Specialist

We are seeking a Quality Specialist to release compounded batches, participate in investigation and root cause analysis of non-conformances, and liaise with relevant stakeholders to complete action items related to quality procedures.

This role involves releasing of compounded batches, participating in investigation and root cause analysis of non-conformances, supplier and customer complaints. You will also participate in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities. Additionally, you will liaise with relevant stakeholders to complete action items related to the above.

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

As a Quality Specialist, you will drive ongoing continuous improvement in Quality performance across the site and the business. This means identifying key areas of focus and implementing improvements to raise compliance and efficiency and engaging with stakeholders to promote the Quality culture.

About You:

  • Experience in a GMP compliant pharmaceutical manufacturing environment
  • Experienced in a sterile compounding environment
  • Experience with regulators of pharmaceutical manufacture 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

You will know that a successful person in this role is someone who can thrive in a fast-paced environment where quality is paramount, whilst displaying a proactive approach, exceptional communication skills, strong leadership and role modelling capabilities.

Why Choose Us?

Icon celebrates diversity and is committed to creating an inclusive workplace for all employees. We encourage applications from all diverse backgrounds.

Our goal is to manage the risk of transmission of specified vaccine preventable diseases. Certain roles may require the successful candidate to show evidence that they have been vaccinated against or are not susceptible to specified VPDs.

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