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Senior CSV Consultant

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Germany

Offer summary

Qualifications:

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.

Key responsabilities:

Act as Senior CSV consultant in IT projects for life science customers
Develop and implement validation strategies, ensure project delivery & coordination

wega Informatik AG Information Technology & Services SME https://www.wega-it.com/

51 - 200 Employees

See more wega Informatik AG offers

Job description

We are a Life Science and IT service provider that has been successfully carrying out 'state-of-the- art' projects for international customers for 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/German area

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. Microfocus ALM, code beamer, JIRA/Xray)