Berufsbezeichnung: Consultant - Quality - SAP Data Steward

Arbeitsbeschreibung:
Position Description: The Global Quality Business Process Representative for ERP is responsible for interacting with both the quality/business and IT organizations to ensure that the global IT system meet the Quality Management System requirements and are in a GMP and CSQ validated and stable state. The role provides the subject matter expertise to ensure business processes are interpreted and implemented effectively and efficiently by the IT, Manufacturing and Quality teams. The QA Representative plays an integral role as a customer liaison in the development of system training, enhancements, reports, bug fixes and trouble-shooting user’s issues that arise. Functions, Duties, Tasks: •Represent business areas requirements within the ERP system and to influence future direction of quality modules, warehouse management and inventory systems. •Assist business partners in defining requirements and in developing business cases. •Ensure Manufacturing sites and affiliates are implementing ERP system as designed and intended. •Point of contact for regulatory audit/inspections on how ERP system is utilized •Subject Matter Expert for cGMP’s and business requirements for the IT system, and business processes connected to the ERP system. •Ensure data steward organization has processes in place for accurate quality master data set up. •Represent business areas requirements within the ERP system and to influence future direction of quality modules •Accountable for maintaining global quality management SOP’s, User Guides, and training programs for the business partners, including approvals as BIQA representative for the ERP system •Provide Business Quality Analyst support for the ERP system and other global M&Q IT systems where needed, including document approvals for GMP related document •Provide consulting support to manufacturing operations and affiliates on interpretation and implementation of Elanco global quality systems and the ERP system for Elanco. •Partner with IT and business partners to establish prioritization of activities •As part of the Stallion project team, define work stream communication plan and provide updates within the project team & across the M&Q functions as required •As part of the Project Stallion team ensure the global business impact of changes related to this work stream, quantify resources required and evaluating technical options. •Assist in prioritization, troubleshooting and root cause analysis of trouble tickets, when needed. •Collaborate with other IT groups to manage integration and solutions to ensure data integrity. •Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies. •Perform any other duties or serve in such other capacity as may be determined by Company management. Experience: •Demonstrated knowledge of Global Batch Release Processes, with a knowledge depth in either FDA and / or EU GMP Batch release requirements •Demonstrated knowledge of enterprise, regional & local business process – across all areas of Quality, from R&D to Manufacturing to Distribution •Effective analytical, problem solving and investigative skills •Ability to communicate effectively in written and verbal form – across a wide range of audiences •Demonstrate interpersonal skills and team work Qualifications: Advanced Degree in an appropriate technical discipline (Chemistry, Chemical Engineering, Biochemistry, Biology). Additional Information: * Location: Basel, Switzerland * Expected travel requirements: up to 20% * Reports to: Senior Director – Quality

Wie Sie sich bewerben: BSL_HR_Switzerland (at) elanco.com

Angestelltenname: Elanco Animal Health Inc.