This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.Provide guidance and support to production team through training and knowledge sharing.Support on going self learning and ensuring training is up to date.Support validation protocol generation and execution.Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.Ensure processes are inspection ready at all times.Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.Investigate deviations and determine root causes and identify CAPA.Identify, assess, and own technical changes through GMP change control processes.Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends. Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.Provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.Support a culture of safety, quality, diversity, and inclusion.This individual is accountable to support process issues, protocol generation, general documentation support, deviation investigations, and continuous improvement of the process. The Manufacturing Process Expert provides direct front line support to production activities using technical understanding and knowledge of cGMPS, SOPs, and process steps. Imagine what you could do here at Novartis! Because the greatest risk in life, is the risk of never trying! And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. That a diverse, equitable and inclusive environment inspires new ways of working. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. 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.
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