Professional CSV Consultant

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February 17

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wega Informatik AG

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wega is your service provider specialized in the Life Science, Pharma and Healthcare industry. Our unique combination of Business, Process and Informatics knowledge enables us to fulfill our demanding mission:

51 - 200 employees

📋 Description

• Act as a Professional CSV consultant in various IT projects for our customers in the life science industry. • Develop tailor made validation strategies for the customers, from V-model to agile validation concepts. • Responsible for project delivery, coordination of CSV project activities, training of project teams. • Responsible for the creation of CSV deliverables, incl. coordination with customer or external resources to ensure consistency and quality overall. • Interact with all (customer) project stakeholders (Business Owner, System Owner, Test Team, Quality Assurance, Business users) as a project member. • Support customers to reach inspection readiness. • Perform CSV related audits. • Act as CSV coach for more junior wega consultants. • Active cooperation in wega internal networks (e.g. CSV, Medical Device, Agile Validation, Templates, Test Automation, regulations and technology related topics). • Develop and conduct CSV Training for wega as well as for customers.

🎯 Requirements

• More than 3-5 years experience in SW Quality Management, SW Testing, CSV or another quality assurance area within a regulated industry. • Advanced knowledge of GxP, 21CFRPart11, Annex 11, GAMP5, SaMD. • Experience in other regulated domain(s) desirable as well. • Strong communication skills in English (writing and speaking, additional languages such as Dutch, German or French would be an asset). • Independent, highly self-organized (multi project assignments in parallel) and intrinsic motivated in sharing knowledge. • Willingness to travel (up to 20%). • Experience with Test Management Tool(s) is a plus (e.g. OpenText ALM, code beamer, JIRA/Xray)