Senior Deviation Specialist

vor 2 Wochen

Visp, Schweiz Lonza Vollzeit

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. The Senior Deviation Specialist will be part of a team that is currently established to own and investigate deviations at our Bioconjugates facilities in MC1 and PCP. The Senior Deviation Specialist represents the Operations Unit, taking ownership of Deviations which arise; to investigate the root cause(s), the (potential) impact on product and/or systems, and to define appropriate CAPA(s) as solutions. What you will get : An agile career and a dynamic work culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found here: Benefits in Visp: What you will do: Responsible to own, investigate, author, and record assigned Deviations. Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations. Ensure accurate investigation tools are used to systematically define all root causes and contributing factors (e.g. Logic Fault Tree, Defense analysis, Event & Causal Factors chart, Fishbone) Define and agree with SMEs appropriate CAPA(s), and associated Effectiveness Checks. Ensure cGMP compliance and consistency through the investigation process and drive their quality records to completion and closure according to scheduled release times. Support the business through ongoing change and process improvement activities. What we are looking for: PhD, Master or Bachelor degree or equivalent experiences in chemistry, biotechnology, life science or related field. Solid experience in Deviations and cGMP in a regulated pharmaceutical or biotech industry. Knowledge of bioconjugation manufacturing processes and analytical methods. Technical writing & presentation/communication skills are key for the role. Experience with Human and Organizational Performance & risk management approaches is an advantage with the ability to work with and manage a team of SMEs without formal authority as well as to deliver full projects working independently. Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive. Fluent in English and German highly desirable. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now. Reference: R71477

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