COMPUTER SYSTEM VALIDATION SUPPORT
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
- 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.
- 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
- 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.
SAP, CSV, (computer System Validation), SAP System, IMB/FDA, Job, career, Ireland