Senior CSV Consultant
Senior CSV Consultant
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Job Description
We are a Life Science and IT service provider that has been successfully carrying out stateofthe art projects for international customers for more than 30 years. Our consultants work either
- from home
- occasionally at our office in Basel
- sometimes on our customers premises
We pride ourselves on being a dynamic forwardthinking organization. We are looking for likeminded individuals with ambitions and highly motivated by interesting jobs as well as financial incentives.
Are you ready for the next step and challenge in your career Do you enjoy working in an environment that values its employees If yes then it is probably the right time to move on and apply for a permanent job @wega.
Your Areas and Responsibilities:
- Act as a Senior CSV consultant in various IT projects for our customers in the life science industry
- Develop tailor made validation strategies for the customers from Vmodel 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
Your Qualification and Experience:
- More than 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 and German (writing and speaking)
- Independent highly selforganized (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)
Required Experience:
Senior IC
Employment Type
Part-Time
