Computerised System Validation Specialist

  • Location

    Crewe, Cheshire

  • Sector:


  • Job type:


  • Salary:


  • Contact:

    Jade Eyre

  • Contact email:

  • Job ref:


  • Published:

    10 months ago

  • Expiry date:


  • Client:


The Role

  • You will provide QA oversight and guidance to ensure that GxP computerised information systems, computerised equipment including automated systems are maintained in a validated state
  • Ensure compliance for all assigned areas of responsibility, systems and activities (e.g. responsible for development, update and maintenance of CSV procedures and related templates, control of pre-archived Q&V packages, periodic review coordination etc.)
  • Support the site by implementing and maintaining standards in accordance with current industry and regulatory guidelines, intelligence and best practice
  • Maintain accurate local and site inventories of computerised systems
  • Provide support to the supplier quality group in relation to the selection of suppliers of computerised systems and related service providers (e.g. takes part in technical audits of CS vendors, supports development of CS vendor questionnaires etc.)

The Fit

  • Degree or equivalent professional qualification in a relevant Scientific, Engineering, Information systems or Quality related discipline
  • You will have a comprehensive understanding of the validation life cycle
  • Knowledge of GxP/GMP is essential
  • Knowledge of GAMP 5 & CFR 21 part 11 and current industry requirements for computerised system validation and data integrity is essential
  • The ideal candidate will be able to work across multi-functional teams and build rapport
  • A pragmatic approach is essential with willingness to compromise

To Apply

If you're ready to apply, great! Click "apply" and if your CV is shortlisted we will call for an initial chat/screening in confidence within the next week.