My client based in the Munster region is looking to recruit a :
Computer Systems Validation Engineer
Minimal experience is required. 12 Months experience & upwards required.
The activities would include:
• Development & execution of the qualification of Information Technologies.
- Development and execution of qualification & validation of Information Systems software.
- Generation, execution, review & approval of IOQ protocols and associated validation documents.
- Prepares/reviews validation documentation related to projects/change controls
- Manages change controls and other compliance related tasks e.g. non-conformances
- Participates in the review of current and future CSV procedures and polices
- Analyzes the results of testing & determines the acceptability of results against predetermined criteria.
- Completion of CSV deliverables including 21CFR11 Assessments, Annex 11 Assessments.
- Generation, Review and Approval of User Requirement Specifications, Functional Specifications etc..
- Installation and Set up of Lab Systems / IPT Equipment.
- Installation and Operation Qualification Protocol Generation, Execution and Reporting for Lab Systems.
- Ensure from a CSV perspective to ensure their continued validated/qualified state.
- Ensure that appropriate Site Validation Listing is established and controlled.
- Review/Approval of all Computer Systems/Software Validation Documentation.
What you'll need !
• Bachelor’s degree in Computer Science, Computer Engineering, etc..
- 12 months to 2 years experience in this area.
For further info please call Colin on 021-4315770 or E-mail me firstname.lastname@example.org
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