Quality Assurance Compliance Professional

7 days ago

Broadmeadows, Victoria, Australia beBeeRegulatory Full time $100,000 - $120,000
Senior Associate, Quality Assurance Compliance

The role of Senior Associate, Quality Assurance Compliance is crucial in maintaining audit readiness and supporting compliance across the organization.

  • Support the Self-Inspection Program, including scheduling, conducting audits, and managing CAPAs.
  • Prepare for and participate in Regulatory Authority and Internal Audits, including inspections by regulatory bodies such as TGA and FDA.
  • Ensure audit findings are addressed and closed out in alignment with regulatory expectations.
  • Maintain and update documentation in electronic quality systems.
  • Collaborate with cross-functional teams to ensure compliance with global regulatory standards.
Requirements
  • Bachelor's degree in Science, Engineering, or a related discipline.
  • 3–5 years' experience in pharmaceutical manufacturing or a highly regulated industry.
  • Experience conducting audits or supporting regulatory inspections.
  • Familiarity with GMP and regulatory frameworks.
  • Preferred familiarity with electronic quality systems such as TrackWise, Veeva, or similar.

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