Compliance Specialist

1 week ago

Broadmeadows, Victoria, Australia beBeeQuality Full time
Compliance Specialist - Quality Assurance

About the Role:

We are seeking a skilled Compliance Specialist to join our Quality Assurance team. The ideal candidate will have experience in pharmaceutical manufacturing, regulatory inspections, and audit management.

  • Main Responsibilities:
  • Support the Self-Inspection Program by scheduling, conducting audits, and managing CAPAs.
  • Prepare for and participate in Regulatory Authority and Internal Audits, including TGA and FDA inspections.
  • Maintain and update documentation in electronic quality systems (e.g., TrackWise, Veeva).
  • Collaborate with cross-functional teams to ensure compliance with global regulatory standards.
  • Support the Quality Management System and contribute to continuous improvement initiatives.

Requirements:

To be successful in this role, you will need:

  • A 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 (e.g., FDA, TGA, EMA).

Our Benefits:

We offer a range of benefits to support your well-being and career development, including opportunities for professional growth, flexible working arrangements, and a supportive team environment.

About Us:

We are a global biotherapeutics leader dedicated to delivering innovative therapies that improve patients' lives. Our mission is to save lives and restore health through the power of innovation and collaboration.

Inclusion and Belonging:

We value diversity and inclusion, recognizing that it fuels our innovation and drives business success. We celebrate our differences and create a culture of empathy and understanding, fostering strong relationships with our stakeholders and sustaining a diverse workforce.

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