Novartis embraces diversity, equal opportunity, and inclusion. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. Thousands of people die of cancer around the world every day. Why Advanced Accelerator Applications (AAA)? Sound experience of data handling and applied statistics and strong in defining and implementing productivity improvement measures.Excellent problem solving and decision-making skills.Strong understanding of risk assessment and risk management fundamentals/tools.Proven process understanding (Pharma GMPs, Aseptic Processing, Validation and Regulatory aspects).Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC (MSc., PhD) a plus Degree in Radiochemistry or Radioactive Products manufacturing is a plus.ĥ years experience in process support, e.g. Provide SME expertise to perform process characterization to increase robustness and sustainability.īachelors degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical engineering, or equivalent scientific degree.Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.Lead/support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.Monitor all critical variables, key variables, In Process Controls (IPC) and release parameters as appropriate using statistical analysis and conducting regular product specific data trending.Create Process Validation protocols and generate reports (as needed) and responsible for ensuring the continued state of validation (process, cleaning, etc.).Support improving the control strategy where applicable. Ensure an appropriate process control strategy is in place based on CQAs and where necessary on CPPs and/or CMAs.Maintain the oversight and knowledge for entire manufacturing process performed on site throughout the entire commercial lifecycle, act as SPOC.Your responsibilities include, but are not limited to: Manages and collaborates with external consultants to achieve document generation and execution according regulatory and project requirements. Provides second line technical/scientific process support. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). The Product Steward owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability through data trending and statistical analysis of critical variables, and ensures process(es) are robust, in continued state of validation and continuously improving. Imagine what you could do here at Novartis! Because the greatest risk in life, is the risk of never trying! 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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