Quality Assurance Specialist

3 days ago

Sydney, New South Wales, Australia Icon Group Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Icon Group. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our sterile compounding services.

Key Responsibilities
  • Release compounded batches in accordance with regulatory and GMP requirements
  • Participate in investigation and root cause analysis of non-conformances, supplier and customer complaints
  • Conduct risk assessments, change control, validation, internal audits, document reviews, CAPA and recall activities
  • Liaise with relevant stakeholders to complete action items related to the above
  • Conduct and coordinate training on Quality procedures and requirements
  • Support the team with Environmental Monitoring activities and perform quality assessments on quarantined incoming goods as required
About You

We are looking for an experienced professional with a strong background in GMP compliant pharmaceutical manufacturing environments. You will have experience in sterile compounding, regulators of pharmaceutical manufacture (e.g. TGA), and continuous quality improvement. You will also have competency in common IT software (MS Word, MS Excel, MS Visio) and be competent in time and task management.

You will be a strong communicator with excellent leadership and role modeling capabilities. You will thrive in a fast-paced environment where quality is paramount and be proactive in identifying key areas of focus and implementing improvements to raise compliance and efficiency.

About Us

Icon Group is a leading provider of sterile compounding services with a strong commitment to quality and compliance. We are part of a global organization with a presence in Australia, New Zealand, and internationally. We are dedicated to delivering the best care possible to our patients and are committed to creating an inclusive workplace for all employees.

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