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Senior Validation Lead (m/f)

Posted on Feb 13, 2019 by Datalynx AG

Kaiseraugst, Aargau Switzerland
Information Technology
Immediate Start
Annual Salary
Senior Validation Lead (m/f)
For our Validation as a Service Team, we are looking for an experienced and ambitious Senior Validation Lead (m/f) in Basel region.
The VaaS (Validation as a Service) service ensures that the CSV tasks are performed providing the necessary deliverables such as Validation Plan or -Report within a project or the lifecycle of a system within defined time and quality.
General information

Start date: ASAP

Work location: Kaiseraugst, Rotkreuz

Work load: 100%

Remote: possible
Tasks and Responsibilities
a) Main tasks:

Plan, lead and report Validation Activities in small to big IT projects
Provide coaching and consulting for IT customers in establishing a compliant system
Ensure that regulatory and pharmaceutical specifications are adhered to additional tasks
b) Responsibilities:

Provide regulatory requirements for a computerized system in all stages of the system delivery process (Define, Design, Build, Test, Deploy)
Participate in system risk and functional risk assessment activities and provide validation subject matter expertise for identification of risks
Determine testing strategy, requirements and acceptance criteria
Provide training CSV related to project teams
Verify system installation and assure configuration control is in place
Participate in the test management and assessment of deviations
Ensure transfer activities meet predefined acceptance criteria
Confirm test results, deviations, issue resolutions and deviations from plan are documented
Confirm traceability and test coverage
Summarize and document all validation activities, including data migration and/or data loading, prior to release a computerized system for use
Ensure any outstanding transition activities are executed in compliance with validation plan
Experience / Skills

Degree in business/IT technical/scientific area or comparable education/experience

10+ years experience in computerized system validation, instrument or software validation or related area within a regulated industry

CSV expert

Experience with GxP / / e-compliance requirements in an IT context

Experience with GAMP 5, ITIL and Risk Management
SAP ERP knowledge is an advantage

Good communication skills, very good written and spoken English and German

Nice to haves

Former Pharma experience (ideally having worked together with an IT quality function in the past)
SharePoint User
Leadership capabilities
We are able to offer you diversified responsibilities in a professional and dynamic international team, performance-matched benefits, and a friendly work environment.
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We look forward to receiving your online application.

If you are not sure whether you should apply or have any questions, please feel free to contact:
Cedrine Hafner

Jetzt bewerben

Reference: 629201148