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Quality Assurance Specialist
2 months ago
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 highest standards of quality and compliance in our sterile compounding operations.
Key Responsibilities- Release compounded batches in accordance with regulatory requirements and company policies.
- Participate in investigations and root cause analysis of non-conformances, supplier and customer complaints.
- Contribute to risk assessment, change control, validation, internal audits, document reviews, CAPA, and recall activities.
- Liaise with stakeholders to complete action items related to quality and compliance.
- 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.
- Experience in a GMP compliant pharmaceutical manufacturing environment.
- Experience 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.
Icon Group is a leading provider of sterile compounding services with a strong commitment to quality and compliance. We are part of a global network of healthcare providers and are dedicated to delivering the best care possible to our patients.
