15 Sep
|
OmniaBio
|
Canada
Elevate OmniaBio's audit preparedness as an Inspection Readiness Specialist based in Hamilton, Ontario. This pivotal role ensures compliance for cell and gene therapy operations through effective audits. As an Inspection Readiness Specialist at OmniaBio, you will oversee all aspects of inspection preparation, including client audits and regulatory inspections.
Collaborating within the Quality Compliance team, you will work closely with unit leaders to maintain GMP compliance and stay audit-ready at all times.
Your responsibilities include planning, organizing SMEs for audits, and addressing audit commitments on time. Key Responsibilities:
- Maintain expertise in GMP compliance for therapies
- Plan agendas and timings for client and regulatory audits
- Organize subject matter experts for successful audits
- Collaborate with business unit leaders to ensure readiness
- Host audits and ensure compliance standards are upheld Requirements:
- Bachelor’s degree in science or engineering
- 5-10 years of relevant industry experience
- Knowledge of compliance in gene production
- Experience in hosting and responding to audits
- Solid understanding of GMP regulations Your role will be crucial in supporting OmniaBio’s commitment to compliance and quality in biomanufacturing.
📌 Inspection Readiness Specialist at OmniaBio (Canada)
🏢 OmniaBio
📍 Canada