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At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
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• Owner & definition of the subject specific content in process descriptions (SOPs, MBRs, forms, …) and for recipes, if applicable, in order to enable the production of plasmatic and recombinant products in the site LA24B.
• Reviewing complaints/ reports, performing change evaluations for equipment and processes and supporting investigations of deviations which are in the related owner’s responsibility. Decision-making for actions to be taken, based on investigation results.
• Apply lean management/ Six Sigma tools if needed
• Work close with the CAPA team to assure adequate investigations and support timely close of CAPAs to assure customer supply
• Participation in projects/ initiatives/ problem solving
• Support the implementation of new products/ processes within the department
• Partner with other functions to optimize results and product value streams
• Identify and implement improvements leading to reduced lead-time, cost reduction, complexity reduction and increased efficiency of own activities, processes and equipment, and assuring that product quality is not negatively affected by the changes/ improvements
• Expert opinion and approval of plans and reports needed for validation of production equipment and processes which are in the owner’s responsibility
• Implementation and compliance with the relevant GMP, Quality and EHS requirements
• Assure inspection readiness against relevant guidelines and requirements (GMP, EHS, …)
• Report accidents or potentially dangerous situations and take corrective and/ or preventive actions
• Support safety standards and EHS measures
• Gemba Walks and supervision of production and processes on demand and in line with department targets