LIMS Technical Documentation

6 days ago

Prague, Hlavní město Praha, Czech Republic futureproof Full time 1,200,000 - 2,400,000 per year

This freelance role focuses on documentation, validation, and testing activities for the LabWare LIMS system within a regulated environment. The specialist supports the SDLC process, drafts and executes test scripts in tools like eVal, and collaborates with both technical and functional teams to ensure changes are properly verified and approved under GxP compliance.

Key Responsibilities

  • Provide functional and validation feedback to technical teams on LIMS configurations.

  • Draft, review, and execute SDLC test scripts (e.g., in eVal) for quarterly and patch releases.

  • Conduct integration and regression testing with other connected systems (e.g., SAP, LabX).

  • Prepare and maintain validation documentation such as test protocols, summaries, and reports.

  • Ensure all deliverables comply with 21 CFR Part 11, Annex 11, and internal SDLC guidelines.

  • Support user acceptance testing and training for site representatives.

  • Participate in audits by providing traceable validation evidence.



Requirements
  • 4+ years of experience with LIMS documentation, validation, and testing.
  • Solid understanding of SDLC and Computer System Validation (CSV) practices.
  • Experience using eVal or similar validation management tools.
  • Familiarity with LabWare LIMS configuration concepts and business logic.
  • Strong technical writing and communication skills.
  • Experience in a regulated pharmaceutical or biotech environment.
  • Bachelor's degree in IT, Life Sciences, or a related field.


Benefits
  • Freelance contract with competitive daily rate.
  • Hybrid working regime - Prague.
  • Long-term cooperation on a global pharmaceutical project with high business visibility


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