Danielle Wright Email & Phone Number

Sydney, Nsw, Au

Toongabbie, New South Wales, Australia

Administration of the Product Complaints and Field Actions process, including and not limited to;• Ensures complaints received are logged correctly and entered into the complaints database as applicable;• Acknowledge receipt of complaint, and closure as applicable;• Coordinates the complaints resolution process. This includes coordinating any root cause investigations with the manufacturing sites and ensuring that relevant stakeholders are involved.• Follow up with manufacturing facilities, technical services and compounding for additional information to ensure complaint closure. • Monitors for recurring trends and implementing continuous improvement to manufacturing and distribution processes.• Ensures timely closure (as per key indicators) of complaints with adequate corrective action either in place or in the process of being implemented.• Respond to MOH failure reports (e.g. Device Incident Reports and Therapeutic Goods Administration Laboratories report).• Notify MOH of Device Adverse Events.• Ensure Device Adverse Events are closed in a timely manner. • Involvement in complaint data analysis as required via A3s, Product Trend Tables, Product Complaints Reporting and Scorecards as applicable.• Maintain the Complaints Manual and review GQPs for compliance.• Co-ordinate Recalls/ Safety Alerts/ Hazard Alerts (Field Corrective Actions) in accordance with the MOH procedures and Baxter Healthcare Corporation requirements in order to conduct recalls as required by the MOH and Baxter.• Perform MOH reporting on recalls as required and follow up. • Back up for Hold System. Place product on Hold in JDE to ensure segregation of product during investigation.• Final release of product status for Technical Service.• Annual Product Reviews.

Toongabbie, Sydney

Toongabbie, Sydney

North Ryde, Sydney