Instrument Validation Specialists

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profile Job Location:

Cincinnati, OH - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Role - Document and validate software installed on lab instrumentation according to EMA guidelines.

Job Description:-

Request for an instrument software validation project involving 200 unique instruments globally. The project involves documenting and validating the software installed on lab instrumentation in accordance with the new EMA guidelines. Additionally it includes migrating the management of the instrument software to the IT software management SOPs.

Project Overview:

  • Document and validate software installed on lab instrumentation according to EMA guidelines.
  • Migrate the management of instrument software to IT software management SOPs.
  • Document the requirements and configuration of the software currently in use.

Tasks to be Completed:

  • Gather and write requirements
  • Write validation test cases
  • Document software specifications
  • Create infrastructure diagrams
  • Create data flow diagrams
  • Perform risk assessments

Required Skills:

  • Technical writing
  • Good communication skills
  • Detail-oriented
Role - Document and validate software installed on lab instrumentation according to EMA guidelines. Job Description:- Request for an instrument software validation project involving 200 unique instruments globally. The project involves documenting and validating the software installed on lab inst...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing