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COMPUTER SYSTEM VALIDATION SUPPORT

 

Company:

PE GLOBAL

Job Reference Number

14606411

Client ID:

RI/JO1223-996

Posted On:

Jun 22 2012

Location:

CARLOW

Job Type:

Contract

Salary:

NEGOTIABLE



Computer System Validation Support

This Computer System Validation Support analyst is an essential resource responsible for a broad spectrum of SAP CSV (computer System Validation) and support activities. The CSV support analyst will be responsible for the re-qualification of the SAP System at our Vaccines Formulation / Fill facility and provide validation support to the deployment of the roll out of the OTC module at the site

Key Responsibilities

  • Accountable for the execution, completion and tracking of computer system validation documentation to the required MErch SDLC standards.
  • Drafting and reviewing of validation documentation and procedures.
  • Actively contribute to project teams.
  • Performing documentation review to support the EPM (Enterprise Process Management)
  • System Support – Assists in the maintenance of SAP fields and hardware used for the SAP system
  • Continuous Improvement – Keeps abreast or a leg of current CSV general knowledge, procedures and business issues in order to facilitate effective and practical solutions to client requests, concerns and inquiries.


Key Experience

  • Computer system validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 – 5 years)
  • Experience in IMB/FDA environment advantageous.
  • Strong technical writing and communication skills
  • Must be goal-oriented and able to manage risks.
  • Project management skills
  • SAP experience desirable
  • Knowledge of Sigma/Lean principles would be an advantage
  • Proficient in the use of personal computers and business software


Education

  • Diploma / BSc associated degree in IT, Business, Engineering, Science or related field


To apply for this position please forward your CV or call Gary Mc Grath on 0214297900.

http://uk.linkedin.com/in/garyjmcgrath/

SAP, CSV, (computer System Validation), SAP System, IMB/FDA, Job, career, Ireland