Senior Compliance Specialist
5 days ago
This role involves maintaining audit readiness and supporting compliance across the site.
Key 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 (e.g., TrackWise, Veeva).
- Collaborate with cross-functional teams to ensure compliance with global regulatory standards.
- Contribute to continuous improvement initiatives within the Quality Management System.
- 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).
- Preferred familiarity in electronic quality systems such as TrackWise, Veeva, or similar.
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