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Validation Analyst (m/f)

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

Background

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: 01.02.2019


• Work location: Basel region


• Work load: 60-100%
  

Tasks and 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


• Participate in the test management and assessment of deviations


• Summarize and document all validation activities, including data migration and/or data loading, prior to release a computerized system for use 

Experience / Skills

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


• 2+ 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


• 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)


• HP ALM


• SharePoint User

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 HafnerRecruiter+41 61 500 01 71cedrine.hafner@datalynx.ch www.datalynx.com

 

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