Quality Assurance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $100,000

Quality Assurance Specialist

We are seeking a detail-oriented and analytical Quality Assurance Specialist to lead our quality assurance functions.

About the Role:

  • Promote a culture of quality within the organisation by developing and implementing robust quality management systems (QMS).
  • Oversee all aspects of quality assurance, inspection, and non-conformance management to ensure regulatory compliance and customer satisfaction.
  • Lead internal audits and drive continuous improvement across the organisation.
  • Train and supervise QA officers and deliver GMP training to relevant staff.

Regulatory Compliance & Certification:

  • Ensure full compliance with Therapeutic Goods Administration (TGA) and other relevant regulatory standards.
  • Act as Authorised Person for the Release for Supply of Finished Products.
  • Manage registration and ongoing compliance of the site with applicable pharmaceutical certifications and regulatory requirements.
  • Facilitate external regulatory audits and ensure only approved products are released to the market.

Product & Process Quality Oversight:

  • Authorise and review written procedures, batch documentation, and other quality-critical documents.
  • Oversee release of packaging materials, bulk products, and finished goods.
  • Monitor and control quality using statistical tools and quality metrics.
  • Implement and manage quality assurance activities including calibration, leak testing, inward and final inspections, and acceptance sampling.

Validation, Storage & Supplier Management:

  • Prepare and manage Validation Master Plan and associated schedules.
  • Monitor storage conditions for packaging materials, retention samples, and finished products.
  • Approve and monitor material suppliers and ensure vendor inspections are completed as required.

Continuous Improvement & Reporting:

  • Conduct regular Quality Review Meetings to ensure alignment across the business.
  • Maintain comprehensive records and ensure proper retention of documents and samples.

About You:

  • Bachelor's degree or higher in a relevant scientific or technical discipline.
  • Minimum 5 years' experience in a quality role within the healthcare, pharmaceutical, or medical device sectors.
  • In-depth knowledge of GMP, TGA regulations, and pharmaceutical packaging quality standards.
  • Strong leadership and communication skills with the ability to train, influence, and lead cross-functional teams.
  • Detail-oriented with strong analytical and documentation skills.

What We Offer:

A challenging opportunity to work with a dynamic team and contribute to the success of the organisation.

Please apply if you have the necessary skills and experience for this position.

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