• Co-operation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production
• Responsible for Quality oversight to review and approval of validation and engineering life cycle documents (URS, FS, RTM, RA, DS, configuration spec, drawings etc), test protocols, CAPAs, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities
• Commissioning and qualification of new Large Scale Manufacturing facility
• Advice the project groups as appropriate and be an active member of the groups where the quality input is needed
• Technically orientated role including experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production
• Self-driven and take ownership and responsibility for own assignments
• Value teamwork at all levels, perform work with an open-mind and ability to value input from colleagues and peers
• Able to drive discussion to solve problems with cross-functional teams
• You will work in an international environment
Projektdauer: 6 MM++
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