Senior Quality Expert

3 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $80,000 - $90,000

We are looking for a Senior Quality Professional to join our team on a fixed-term contract.

About the Role:
  • The Senior Quality Professional will be responsible for supporting the management of our Quality Management System, ensuring continued compliance with relevant regulations, guidelines, and industry standards.

Key Responsibilities Include:

  • Creation, review, and approval of controlled documents
  • Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements
  • Preparation of Product Quality Reviews
  • Investigation and management of non-conformances, CAPAs, deviations, and complaints
  • Assistance with audit findings and audit management
  • Cross-functional support of design and manufacturing, including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etc.
  • Conduct of other routine QA duties such as issue and review of batch documentation, incoming, and finished goods release
  • Plan and execute assigned process improvement projects
Required Skills and Qualifications:
  • University degree in Science or Engineering
  • At least four years' experience in GMP within Pharmaceuticals, Medical Devices, or related field
  • At least two years' experience in a QA role
  • High level of verbal and written communication and numeracy skills
  • Thorough knowledge of standards and governing bodies
  • Excellent problem-solving skills
  • Proficient attention to detail, excellent written and verbal communication skills
  • Ability to work as part of a team

This is an exciting opportunity to join a dynamic organisation that values diversity & inclusion. We are committed to providing products, services, and solutions that improve clinical outcomes every day.

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