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Quality Manager (f/m/d) (Melsungen, DE) @ B. Braun Melsungen AG

Melsungen, Hesse, DEOnsiteFull-time
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About this role

For B. Braun’s Group Digital Department (GDD) we are looking for a Quality Manager (f/m/d) to support our computerized system validation activities.

Tasks and responsibilities

Develop, maintain, and improve processes, templates, and guidance for qualification and validation of computerized systems in accordance with GAMP 5 and internal requirements Support projects in planning and executing risk-based qualification and validation activities for computerized systems, including internally developed cloud services and web applications Create, review, and maintain qualification and validation documentation, such as plans, risk assessments, requirements, test documentation, traceability matrices, and reports Ensure qualification and validation requirements are appropriately integrated into system development, implementation, operation, and change management processes Develop and deliver training on qualification and validation processes and act as a subject matter expert within the GDD organization Professional

Qualifications

Degree in Computer Science, Engineering, Information Technology, Quality Management, or a comparable field Proven experience in Computerized System Validation (CSV), qualification, software quality assurance, or a related quality management discipline Good knowledge of GAMP 5 principles and risk-based qualification and validation approaches Experience with cloud-based services, computerized systems, and software development processes Ability to create and review qualification and validation documentation and quality procedures Strong written and verbal communication skills in English Personal

Qualifications

You have a sense for details, are driven to deliver and retain an overall perspective You can balance well between setting high quality standards and fast execution You are a self-starter, a continuous learner, and an explicit networker You have an agile mindset und enjoy working in a start-up environment

Benefits

Company pension scheme Mobility benefits, e.g., the B. Braun Job Ticket or Job Bike Family-support services, e.g., vacation childcare Flexible working hours such as flextime and mobile work Employee discounts Various working models, e.g., job sharing/part-time Diversity makes us stronger! That is why we explicitly encourage people of all identities, lifestyles, and backgrounds to apply. B. Braun SE | Haakon Schröder

Skills

computerized system validationGAMP 5risk-based qualificationCloud ServiceSoftware DevelopmentQuality Managementtraceability matrixtest documentationagile mindsetjob sharing

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