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Software Validation and Verification Support

Location: Zug, Switzerland
Sector: Computer System Validation & Quality Assurance
Job Type: contract
Salary: Swiss Franc80 - Swiss Franc85 per hour
Reference: BBBH114643

Software Validation and Verification Support

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.

One of our clients, a leader in the pharmaceutical industry, is looking for a Software Validation & Verification Specialist with experience in CSV & GxP. This is a 12-month contract located in Zug, Switzerland.

Job summary

In this project you will be developing a new calculation engine which supports our client in the evaluation of manifold raw data, algorithms and other important documentation.

Tasks & responsibilities

Main activities (80%)

  • Validation / documentation and qualification of the raw biochemical data generated at the end of the sub-processes
  • Creation of test plans for testing the software and scripts that control test / test procedures in development
  • Validation of test software and test scripts as well as Excel workbooks according to CSV (Computerized System Validation), which ensure test procedures / results from the development environment and connect to databases
  • Qualification of test / test systems (custom built, consisting of various subsystems)
  • Requirements Management (contact with stakeholders to define URS)
  • Change Board
  • Training setup Lead

Secondary activities (20%):

  • Development of the support basics with the information from the last partial processes and the further evaluation of the received project specific data about further coordination in the project. Furthermore, you are the contact person for the technical advice of the operators and users of the equipment / systems
  • Project coordination, cooperation, planning and coordination of priorities in meetings with production and project managers of RMD Development orders for custom-made test systems
  • Documentation of validation / qualification activities according to internal manufacturing process according to valid specifications and project planning
  • Creation of risk analyses for equipment / software / systems
  • Support and technical advice to operators and users of equipment / systems in the execution of validation and qualification

Must haves

  • Experience in drafting process documentation or qualification documentation
  • 2-5 years' experience in validation, (Qualification and CSV Computer System Validation) or close validation and qualification programs
  • At least a university degree in engineering, medicine or biophysics or completed training with at least 2 years of experience in process management and the development of project documentation in the affiliated technical departments, Medicine, Biology / Chemistry
  • Fluency in spoken and written English (Documentation in English)

Nice to have

  • MS Office / HP ALM / TFS (Team Foundation Server)
  • Previous experience in medical technology (ISO 13458, GMP, FDA 21 CFR 820) or GxP Experience
  • Introverted working technique with communicative flair within the line / stakeholder
  • Abstract thinking for the recognition of complex contexts
  • Knowledge of German
  • Software understanding

General information

  • Start date: 06/01/2020
  • Latest start date: 01/02/2020
  • End date: 31/12/2020
  • Extension: possible
  • Place of work: Zug
  • Team: 15-20 project members / 3 Project Leaders / 1 line manager
  • Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell on +41 61 282 22 16, at www.linkedin.com/in/alex-russell-experis/ or via email

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