Computer Systems Validation Consultant required for a 12 month hourly rate contract with a reputable Biotech company in Co. Limerick.
Essential Duties and Responsibilities:
* Manages change controls and nonconformances.
* Review of CSV procedures and policies.
* Analyses the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerised operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Coordinates with other departments or outside contractors/vendors to complete validation tasks.
* Participates in regulatory audits.
Education and Experience:
* Requires BS/BA in Engineering, Chemistry, or Life Sciences.
* 5+ years of related experience within the fields of Automation and Computer systems and IT.
* Experience in a GMP environment.
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