Professional CSV Consultant - Remote

Overview

We are a Life Science and IT service provider that has been successfully carrying out 'state-of-the-art' projects for international customers for more than 30 years. Our consultants work either from home, occasionally at our office in Basel, or sometimes on our customer's premises.

In Short

• 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, ensuring consistency and quality overall.
• Interact with all project stakeholders as a project member.
• Support customers to reach inspection readiness.
• Perform CSV related audits.
• Act as CSV coach for more junior consultants.
• Cooperate in internal networks related to CSV and other topics.
• Develop and conduct CSV Training for wega and 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.
• Strong communication skills in English; additional languages such as Dutch, German or French would be an asset.
• Independent, highly self-organized, and 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).

Benefits

• Dynamic and forward-thinking organization.
• Interesting jobs with financial incentives.
• Opportunity to work from home.
• Collaboration with international customers.
• Professional development opportunities.