Supplier Quality Expert
2 settimane fa
Maintain quality oversight for Contract Manufacturing Operations (CMOs) utilized by GE Healthcare Pharmaceutical Diagnostic (PDx) Division.
Develop, monitor and maintain positive relationships with GE External CMO partners, encouraging strong collaboration, continuous improvement, transparency, and accountability.
Ensure manufactured sterile Finished Product meets or exceeds GE Healthcare quality, safety, and regulatory requirements.
Key Responsibilities:
- Complete supplier qualification activities for prospective Contract Manufacturing Operations.
- Maintain quality oversight for a number of Contract Manufacturing Operations.
- Act as a single point of contact for all quality-related activities at Contract Manufacturer.
- Manage all critical quality-related issues (deviations, complaints, regulatory non-compliances, etc).
- Assure Corrective and Preventive Action plans are developed and executed appropriately.
- Develop and maintain Quality Agreements between GE Healthcare and Contract Manufacturers.
- Responsible for the coordination and completion of audits, participating in and/or leading audits.
- Ensure Change Controls, initiated by supplier or by GE Healthcare, are managed appropriately.
- Assist in Health Authority inspection preparations and providing support throughout as required.
- Track and trend key quality indicators/metrics to monitor supplier and QMS performance.
- Assure suppliers comply with all GE Healthcare QMS, procedures, and regulatory requirements.
- Develop positive relationships with all internal partners, i.e., Sites, Sourcing, Supply Chain, etc.
- Provide quality support for New Product Introductions and transfers project activities.
- Interact with Suppliers, Sites, and Sourcing to drive improvements to minimize costs of quality.
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