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Auditor, Pharmaceutical Manufacturing

2 weeks ago


Broadmeadows, Victoria, Australia beBeeCompliance Full time
Compliance Specialist

We are seeking a Compliance Specialist to join our Quality team. The role will involve maintaining audit readiness and supporting compliance across the site.

The ideal candidate will have 3-5 years' experience in pharmaceutical manufacturing or a highly regulated industry, with knowledge of GMP and regulatory frameworks. Familiarity with electronic quality systems such as TrackWise, Veeva, or similar is also an advantage.

Your Role and Responsibilities
  • Support the Self-Inspection Program, including scheduling, conducting audits, and managing CAPAs.
  • Prepare for and participate in Regulatory Authority and Internal Audits, including TGA and FDA inspections.
  • 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.
  • Support the Quality Management System and contribute to continuous improvement initiatives.
Your Skills and Qualifications
  • Bachelor's degree in Science, Engineering, or a related discipline.
  • Excellent communication and analytical skills, with the ability to work independently and as part of a team.
  • Familiarity with quality management systems and regulatory requirements.
  • Strong problem-solving and organizational skills, with the ability to prioritize tasks and manage multiple projects.
  • Ability to adapt to changing priorities and deadlines.
Our Benefits

We offer a range of benefits to support your well-being and career development, including professional growth opportunities, flexible working arrangements, and access to training and development programs.

We value diversity and inclusion and are committed to creating a workplace that reflects the communities we serve. We encourage applications from candidates who share our values and are passionate about making a difference.

About Us

We are a global biotherapeutics leader driven by our promise to save lives. We discover, develop, and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular, and metabolic therapeutic areas.

We operate one of the world's largest plasma collection networks and employ a diverse workforce of over 32,000 people. We are committed to sustainability and reducing our environmental impact.

We believe that every employee has the potential to make a significant contribution to our organization and are committed to providing opportunities for growth and development.