Sterile Pharmaceutical Specialist

2 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $70,000 - $110,000

Our company specializes in the preparation of sterile pharmaceutical products, seeking a skilled professional to oversee quality control and compliance.

The ideal candidate will have experience in Good Manufacturing Practice (GMP) compliant pharmaceutical manufacturing, with a focus on ensuring high-quality standards and regulatory adherence.

This role involves releasing compounded batches, participating in investigations and root cause analysis, and conducting training on quality procedures. You will also drive continuous improvement in quality performance across the site and business.

Key Responsibilities:

  • Release compounded batches
  • Participate in investigation and root cause analysis of non-conformances, supplier and customer complaints
  • Participate in risk assessment, 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

In addition, you may support the team with Environmental Monitoring activities and perform quality assessments quarantined incoming goods as required.

Our organization has a strong commitment to delivering high-quality services and has been providing aseptically compounded pharmaceutical products for use by patients in hospitals for over 50 years.

We are committed to continuous improvement and strive to maintain high standards in our processes and operations.

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