Quality Assurance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $80,000 - $110,000

Job Title:

Quality Assurance Specialist

The Quality Assurance Specialist plays a crucial role in ensuring the compounding centre adheres to regulatory and GMP requirements.

This includes releasing compounded batches, participating in investigations and root cause analysis of non-conformances, and liaising with stakeholders to complete action items.

The ideal candidate will have experience in a GMP compliant pharmaceutical manufacturing environment, particularly in sterile compounding. They should also be competent in common IT software, time and task management, and possess a tertiary qualification in a Science or relevant discipline.

Key Responsibilities:

  • Release of compounded batches.
  • Participation in investigation and root cause analysis of non-conformances, supplier and customer complaints.
  • Participation in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
  • Liaison with relevant stakeholders to complete action items related to the above.
  • Conducting and coordinating training on Quality procedures and requirements.
  • Additionally, 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 or relevant discipline.

What We Offer:

A challenging and rewarding role within a dynamic team, where you will have the opportunity to contribute to the delivery of high-quality products.

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