Validation Specialist

CPL

Dublin West

The Validation Specialist is responsible for the coordination of all validation activities on site ensuring compliance with current regulatory requirements. The Validation Specialist will have specific and varying duties as assigned by the Quality Director. Some key tasks and responsibilities are outlined below. RESPONSIBILITIES: Provide expertise in the area of validation, ensuring compliance with current industry regulations, guidelines and trends. Coordinate execution of all validation activities at including the following: Computer system qualification. Qualification of premises, equipment and utilities. Laboratory equipment validation. Process validation. Cleaning validation. prepare and maintain policies and SOPs associated with validation. Prepare and maintain site validation master plans, protocols and reports. Review validation documents prepared by other personnel as required. Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities. Participate in cross-functional project teams as the validation representative. Coordinate the periodic review and revalidation programme. Ensure that all change controls are assessed for impact on validation. Participate in Continuous Improvement programmes. Participate in other projects as directed by the Quality Director. EDUCATIONAL REQUIREMENTS: Primary degree in scientific, engineering or other relevant discipline. RELEVANT EXPERIENCE: A minimum of 5 years’ experience in a validation role in the pharmaceutical industry. Computer systems validation experience is required. This job originally appeared on RecruitIreland.com.

2383 days ago