Quality Assurance and Compliance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $100,000
Quality Assurance Specialist

This is a key role that involves driving the development and continuous improvement of our Quality Management System, ensuring compliance with regulatory standards to deliver safe, high-quality products from concept to market.

Key Responsibilities:

  • Drive compliance with regulatory standards including TGA, PIC/S GMP, Medsafe and NZ Dietary Supplement regulations
  • Review and approve product specifications, labels and listings across the product lifecycle
  • Own preparation and maintenance of product Listings in the TGA EBS
  • Approve marketing and promotional materials in line with the Therapeutic Goods Advertising Code
  • Lead audits, supplier qualifications and non-conformance resolution
  • Drive continuous improvement of the Quality Management System (QMS)
  • Investigate complaints, deviations and implement effective CAPAs
  • Build and maintain robust evidence packages to substantiate product claims
  • Monitor pharmacovigilance systems and escalate safety concerns
  • Stay ahead of regulatory changes and champion a culture of quality and compliance

Requirements:

  • A degree in Pharmaceutical Science, Chemistry, Pharmacy, or related discipline
  • Minimum 3 years' experience in Quality Assurance and/or Regulatory Affairs within the TGA medicines sector
  • Strong knowledge of GMP, QMS, and therapeutic goods regulatory frameworks
  • Exceptional attention to detail, documentation and organisational skills
  • Excellent communication skills, with the ability to collaborate across diverse teams
  • A proactive, adaptable, and ethical approach with high levels of professionalism and integrity

To succeed in this position, you will need to demonstrate a strong understanding of regulatory requirements and a passion for delivering high-quality outcomes. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply today

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