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Job Details


Deviation Specialist

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Wilson, North Carolina, United States

With 53 manufacturing sites across the globe, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry. <br><br>A successful Deviation Specialist will perform and assist with the deviation investigation process for assigned deviations by applying technical, quality, and process skills to conduct investigations! Lead under the supervision and guidance of Deviation Manager the investigation of deviations that occur in operations. Work cross-functionally with Quality Assurance, Quality Control, Operations, Engineering, Maintenance, Calibration, Safety, and Supplier Quality Management to ensure appropriate and timely determination of scope, batch disposition, root cause, and corrective actions. Interact with all levels of staff and provide status updates as well as support the strategy for closure of deviations. Lead several investigations simultaneously.<br><br>• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance<br>• Support exception investigations<br>• Review & approval of production, QC, and AS and T records<br>• MBR review<br>• Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration<br>• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt<br>• Distribution of marketing samples (where applicable)<br><br>[#video#https://youtu.be/HUSA096Nn_E{#400,300#}#/video#]