WORK WITH US

QSTEP IS RAPIDLY

EXPANDING

Join our young team and you will have the opportunity to grow rapidly in the world of Computer System Validation, Data Integrity and IT Compliance for the Life Sciences sector.

Qstep is one of the few companies on the market where consultants have the opportunity to participate in Computer System Validation and Data Integrity projects on computerised systems used in all areas of the drug development process: from research to production.

OPEN POSITIONS

The search is open for both senior and junior figures in the role of Computer System Validation & Data Integrity consultant.

Minimum requirements for the role:

  • Degree in science and/or engineering
  • Fluent English
  • Excellent verbal and written communication skills in Italian and English (at least B1 level in English required)
  • Excellent knowledge of Office Suite (Outlook, Word, Excel, PowerPoint)
  • Knowledge of GxP regulations
  • Knowledge of international guidelines on validation of computerised systems and data integrity

The CSV & DI consultant at Qstep will, depending on the seniority level of the role, be responsible for:

  • Drafting of Validation Plan and Validation Report documents
  • Conducting Data Integrity Assessments
  • Performing GxP Risk Assessment on computerised systems
  • Review of technical documentation
  • Drafting and reviewing test and qualification protocols (IQ, OQ and PQ)
  • Test execution support
  • Management of Change Control and Periodic Review processes
The work is home-based and travel throughout the country is planned.
Position and salary will be commensurate with the experience of the selected profile.
This announcement is aimed at both sexes pursuant to law 903/77.
Send your CV to