Leading Quality Assurance Professional

16 hours ago

Melbourne, Victoria, Australia beBeeQuality Full time $100,000 - $140,000
Senior Quality Assurance Role

This exceptional opportunity allows you to contribute significantly to the quality standards of a renowned biopharmaceutical organisation.

Key Responsibilities:
  • Manage third-party and regulatory inspections across the site, ensuring seamless compliance with global standards.
  • Lead internal audits and implement a robust self-inspection program to maintain quality excellence.
  • Maintain quality agreements with internal and external partners, fostering strong relationships and collaboration.
  • Drive quality risk management and change control processes, mitigating potential risks and improving overall performance.
  • Analyse and report on site KPIs, APQRs, and global quality metrics to inform strategic decision-making.
  • Support the implementation and maintenance of the Quality Management System, ensuring its effectiveness and efficiency.
Requirements:
  • Minimum 3 years' experience in a GMP-regulated pharmaceutical or biopharmaceutical environment, with a strong track record of delivering quality results.
  • Strong knowledge of global regulatory standards and QMS, enabling you to navigate complex compliance requirements.
  • Experience managing audits and compliance programs, with a focus on continuous improvement and process optimization.
  • Ability to critically analyse data and provide insightful recommendations to drive business growth.
  • Strong stakeholder engagement, written and verbal communication skills, and a collaborative approach to teamwork.
  • Degree in Science, Pharmacy, Engineering, or related discipline, demonstrating your academic foundation in quality assurance principles.

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