Your responsibilities: Your responsibilities include, but are not limited to: • Support and approval of investigations of deviation • Evaluation and approval of CAPAs, Risk Assessments • Release decision on the...
Your responsibilities: Your responsibilities include, but are not limited to: • Ensuring GMP Compliance in Production • Support and approval of investigations of deviation • Evaluation and approval of CAPAs,...
Your responsibilities: Your responsibilities include, but are not limited to: • Formulate, lead and drive global CMC regulatory strategy for certain modality projects/products drawing on substantial regulatory expertise...
Your responsibilities: Your responsibilities include, but are not limited to: • Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for biosimilar...
Your responsibilities: Your responsibilities include, but are not limited to: • Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance...
Your responsibilities: Your responsibilities include, but are not limited to: • Represent the technical Interface to external supplier to ensure robust product process capability • Responsible for validation oversight...
Your responsibilities: Your responsibilities include, but are not limited to: • Support the implementation and administration of a manufacturing execution system (MES) as an active member of the automation Plant 1 team...
Your responsibilities: Your responsibilities include, but are not limited to: • Design, plan, perform, interpret and report results of scientific experiments and analytics. These are related to method development and stability...
Your responsibilities: Your responsibilities include, but are not limited to: • Drive the implementation of lean, scientific and compliant documentation by improving documentation processes and establishing innovative...
Your responsibilities: Your responsibilities include, but are not limited to: Provide technical manufacturing expertise during device development stages Translate device design output requirements into production site specific...
Ihre Aufgaben: Sind unter anderem: • Erstellung von produktionsrelevanten Dokumenten (z.B. Master Batch Record, themenbezogene SOPs) und von Studienprotokollen/Studienberichten in Zusammenarbeit mit den...
Your responsibilities: Your responsibilities include, but are not limited to: • Providing scientific support for the commissioning, qualification and ramp-up of the Biofuture Plant 1 • Implementation and supervision...
Your responsibilities: Your responsibilities include, but are not limited to: • Lead mechanical design development activities in projects • Work with cross-functional teams for easy-to-use, robust products: human...
Deine Aufgaben: Selbstständige Bedienung und Betreuung von zugewiesenen Infrastrukturanlagen unserer Standorte Kundl bzw. Schaftenau unter Einhaltung aller qualitäts- und sicherheitsrelevanten Erfordernisse...
Your responsibilities: Your responsibilities include, but are not limited to: • Responsible for the preparation of and participation in internal and external inspections covering GMP • Act as single point of contact...
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