Development and definition of validation strategies for routine processes and project activities at the Singen site, taking into account regulatory requirements and current industry standards.
Support with documentation, execution and evaluation of Aseptic Process Simulation (APS)
Creation, maintenance, and release of validation documentation within the framework of the Lifecycle Process Validation concept, including data analysis, data evaluation, and the preparation of results and final reports. Ensuring consistency between manufacturing processes and the validation activities performed.
Responsibilities
Development and definition of validation strategies for routine processes and project activities at the Singen site, taking into account regulatory requirements and current industry standards.
Support with documentation, execution and evaluation of Aseptic Process Simulation (APS)
Creation, maintenance, and release of validation documentation within the framework of the Lifecycle Process Validation concept, including data analysis, data evaluation, and the preparation of results and final reports. Ensuring consistency between manufacturing processes and the validation activities performed.
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