Computer Systems Validation Contractor

CPL

Limerick

Essential Duties and Responsibilities include, but are not limited to, the following: Generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments. 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 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. Coordinates with other departments or outside contractors/vendors to complete validation tasks. Participates in regulatory audits and communicates companys computer validation policies. Assesses companys computer systems and identifies any potential Part 11 or Annex 11 gaps. Manages projects and prepares status reports using Microsoft project and other communication tools. Education and Experience: Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of (Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education. Experience in a GMP environment essential. For more information, please contact frances.lambe@cpl.ie or call 061208643. This job originally appeared on RecruitIreland.com.

1928 days ago