Senior Quality Assurance Specialist

1 day ago

Newcastle, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Job Description

The Senior Quality Associate will be responsible for supporting the program across the broad spectrum of quality initiatives, ensuring quality across all aspects of the organization.

This role will join a team working exclusively on the project at a leading research institute in Newcastle, collaborating with experts to drive quality improvements and best practices.

  • Support manufacturing activities including batch record collection and batch reviews.
  • Develop, manage, and implement the Quality Management System (QMS) spanning R&D activities, product development, and commercialization activities.
  • Manage GxP vendor qualification, audits, and reviews.
  • Facilitate investigations, deviations, and CAPAs within the QMS.

Key Responsibilities:

  • Ensure compliance with regulatory requirements and industry standards.
  • Develop and maintain policies, procedures, and work instructions.
  • Conduct audits and assessments to identify areas for improvement.
  • Implement corrective actions and preventive measures.

Required Skills and Qualifications:

  • Degree in biological or biomedical sciences, pharmacy degree, or comparable.
  • At least 3 years' quality management experience in the pharmaceutical/biotechnology industry.
  • Experience within GxP; especially the cGMP environment.
  • Strong English language skills - verbal and written.
  • Superior level of skill and attention to detail regarding editing and manipulating documents.

Benefits:

  • Opportunity to work in a dynamic and collaborative environment.
  • Professional development and growth opportunities.
  • Competitive salary and benefits package.

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