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Validation Lead (m/f)

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For our Validation as a Service Team, we are looking for an experienced and ambitious Validation Lead (m/f) in Basel region.

Validation Lead (m/f)


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
  • 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
  • 5+ years experience in computerized system validation, instrument or software validation or related area within a regulated industry
  • Experience with GxP / CSV / 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 (both mandatory)

Nice to haves

  • Former Pharma experience (ideally having worked together with an IT quality function in the past)
  • HP ALM
  • 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.

* * *
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
+41 61 500 01 71



Datalynx AG
Frau Cedrine Hafner
Steinengraben 22
4051 Basel

Website https://www.datalynx.com/de

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