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
- sometimes on our customer's premises
We pride ourselves on being a dynamic forward-thinking organization. We are looking for like-minded 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.
Work Place: remote/the Netherlands
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 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
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 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)
Top Skills
What We Do
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: “Building the bridge between business and IT” We offer comprehensive, sustainable and high quality 360° services. Our employees possess deep expertise due to holding a dual qualification in the scientific as well as in the technical domain. Our core skills range from Lab and Research, Clinical Development and Healthcare to Computer System Validation. In addition, we are focused in the development of sector independent software solutions. A continuously growing, excellent network of highly specialized temporary contractors and freelancers complement our competencies. Having acquired 30 years of experience and a very high customer satisfaction, wega is one of the most established and well-respected service providers within DACH, France and BENELUX
