Quality Assurance Specialist

7 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $115,000

Job Title: Quality Assurance Specialist

We are seeking a seasoned quality assurance professional to oversee compliance with regulatory requirements and maintain high-quality standards within our organization.

About the Role

This is an exceptional opportunity for a skilled quality assurance manager to lead and train QA, QC, and Regulatory Teams in ensuring adherence to cGMP and quality systems.

  • Lead audits from regulatory bodies and clients' audits
  • Ensure compliance with TGA requirements
  • Develop and disseminate SOPs related to quality assurance
  • Schedule and conduct training of personnel in cGMP, relevant SOPs, and quality systems
  • Carry out Supplier/Vendor Qualification for all starting materials
  • Handle Supplier Corrective Action Reports (SCARs)
  • Manage Change control
  • Manage Deviations
  • Conduct Product Validation; make Stability Testing Protocols and ensure products are tested as per the protocols
  • Develop protocol for IQ/OQ/PQ and carry out IQ/OQ/PQ for production & packaging machinery
  • Schedule and conduct Environmental Monitoring
  • Ensure analytical testing is carried out as per relevant monographs
  • Reconcile Batch documents
  • Release Finished products for Sale/Supply
  • Carry out Risk Management; and PQRs (Product Quality Reviews)
Key Requirements

The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.

We offer a competitive salary package and opportunities for professional growth and development.

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