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Job Details


Process Specialist (344629BR)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Millburn, New Jersey, United States

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis!<br><br>The Process Specialist will author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing and engineering department. Provide support to shop floor by triaging of unexpected events with PU Supervisors and QA team. <br><br>Your responsibilities include, but are not limited to:<br><br>Deviation and Investigation Management:<br>• Support the shop floor in the triage of unexpected events<br>• Open deviations within required timeframes<br>• Author investigations and support resolution of product complaints <br>• Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.<br><br>Corrective and Preventative Actions:<br>• Generation and documentation of effective corrective and preventative actions<br>• Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)<br>• Monitor and ensure effectiveness checks of CAPAs are conducted<br>• Communicate to the production team any training or awareness events to reinforce quality behaviours. <br><br>Communication and Process Improvements:<br>• Provide timely updates to management on status of all GMP-related investigations<br>• Identifies opportunities for operational improvements for both manufacturing/engineering and deviation/investigation management<br>• Work with Scheduling, QA, to ensure that batches are released on time through the closure of robust investigations and impact assessments.<br><br>Quality Events:<br>• Owns and manages Quality Events related to GMP manufacturing<br>• Communicates, escalates, initiates, and owns trend events under the QE module. Ensure that the required CAPAs are communicated and created in order to eliminate or reduce reoccurrences.<br><br>Site Quality and Compliance<br>• Support the site during self-inspection, audit/inspection readiness and support the backroom/frontroom if required.<br>• Support the Novartis and Site Quality Plan, completion of site trend reports, APQR data gathering, and support KPI reporting.<br><br>https://www.youtube.com/watch?v=4A1joFLTfo0