Digital Quality - Quality Systems Engineer Laboratory Operations

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As a Digital Quality Systems Engineer Lab Operations, you will be a member of the QC Lab Systems team. You will manage set of projects with the focus on Laboratory Information systems (such as Labware and MODA). You will also ensure Takeda QC Labs with Global Laboratory Information Management Systems/GME solutions (such as Empower and Chromeleon) per Global Lab Systems roadmap. You will be a bridge between the Business (Need) and the Technology (Solutions). You will report to the Manager Business Systems.

• Work with the Takeda laboratories to help them understand their requirements around the following workflows: Environmental Monitoring, Raw Materials receiving and inspection, Standards and reagent management and testing, Lot/batch QC testing and release, stability testing of products, test instrument management.
• Assess proposed solutions to help the partners select the solution which best fits their requirements.
• Plan the tasks and activities for Business Analysis including stakeholder analysis, managing issues, risks and requirements, and monitoring and reporting on business analysis activities.
• You will oversee and participate in the architectural design, development, customization and integration efforts.
• Provide oversight of vendor-provided solutions and handle ad-hoc technical requests from both internal and external partners.
• Support the IT systems owned by the group and will be part of the on-call support team once training is complete.
• Manage work and be the technical lead for complex IT systems and projects.

• Bachelors degree preferred or relevant work experience in systems or business.
• In-depth understanding of Laboratory Systems.
• 2+ year experience using at least one of the following systems, MoDa, Labware would be ideal.
• Knowledge of Labware and Moda and HPAlm (Application Lifecycle Management) testing tools, Jira, Toad and Powershell would be ideal.
• Experience with outsourced vendors a distinct advantage.
• Working knowledge of: SCRUM, Agile Methodologies, Change Management, Project Management
• Gather, understand, and document business processes, goals, specifications, and requirements on medium/large size projects.
• Knowledge and/or use of GxP, 21CFR Part11 and industry best practices would be ideal.
• Experience in validated systems.

• A competitive remuneration package with a minimum salary of € 3 909,67 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
• Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
• Work @ home depending on the position / department
• Comprehensive training programs
• In-house job rotation program
• In-house Canteen with discounts or meal vouchers
• Works council (events, festivals, shopping vouchers, etc.)
• Employee Referral Program
• Employee Recognition Program
• Takeda Resource Groups
• Medical checkups
• Free vaccination program
• Fitness Center

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.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.