Computer System Validation Consultant

UNIT: Validation

We’re looking for a Computer System Validation Consultant figure. The profile sought has a Master’s degree in technical/scientific disciplines, preferably Computer Engineering/Biomedical/Mechanics/Management, Biotechnology or CTF and an experience of at least two years

 

What we will do together

The candidate, through appropriate support, will be used to support CSV and Data Integrity projects and in major activities such as:

  • Write Validation Plan and Validation Report
  • Conducting Data Integrity Assessment and Remediation
  • Running GxP Risk Assessment on Computer Systems
  • Issuing, compiling, and reviewing software validation documentation (including user requirements, technical specifications, and test protocols)
  • Issuing and reviewing qualification test protocols (IQ, OQ and PQ)
  • Manage change control and periodic review processes
  • Training as a trainer on CSV and Data Integrity topics to clients 

What we are looking for

  • Knowledge of GxP regulations
  • Knowledge of 21 CFR part 11 and Annex 11
  • Knowledge of international data integrity guidelines
  • Excellent knowledge of the English language
  • Excellent analysis capability
  • Problem solving
  • Self-sufficiency in use in word processing and spreadsheet software
  • Ready for teamwork
  • Availability for travel

What we have in common

Reliability, accordance, respect, care, curiosity, courage, perseverance and passion are the values ​​that represent us. If you have these values in common with us, send your application.

APPLICATION

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