Validation Supervisor
CPL
Dublin West
The primary purpose of the Validation Supervisor role is to ensure that the validated status of all systems on site are maintained, in accordance with pharmaceutical standards. Main Responsabilities: Risk Assessment, IQ, OQ, PQ, PV, CPV Validation and Periodic review. Validation of process equipment (manufacturing, filling and packaging) and utilities, and facility qualifications. Re-Validation of existing manufacturing and cleaning processes, equipment, utilities and facilities. Writing and reviewing of protocols, reports, assessments and SOP’s required for the above. Scheduling and execution of validation studies, in co-operation with external vendors/ consultants where required. Giving input into planning materials, human resources, and time frames for multiple Validation studies. Ensuring that the personnel involved in the validation studies have relevant training. Evaluating deviations and change controls relevant to the validation study. Skills & Experience ; Minimum 4 year’s experience as a Validation Engineer within the pharmaceutical industry or similarly regulated industry. Experience in aspects of Engineering, QA, validation and GMP. Projecct management skills for multiple projects. Presentation and explanation of validation work to inspectors and other third parties. A Degree in Engineering. Salary: Salary €45,000-60,000 DOE. Additional Benefits Package. This job originally appeared on RecruitIreland.com.
2383 days ago