Job Description

An exciting start up Pharma site in Tipperary is seeking an experienced QA Validation Specialist. On offer is a competitive salary in a collaborative environment on an initial 12 month contract. In this role you will ensure Qualification of Equipment / Systems / Facilities and Utilities is performed in compliance with regulatory requirements, company policy and procedures. Support to production / engineering to ensure the qualified state of equipment, systems, facilities and utilities are maintained. Implement cleaning validation program for production equipment. About the Job: • Review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation • Support execution of Qualification / Re-Qualification and Validation activity. • Generates and executes project validation plans and validation master plans. • Co-ordinates with manufacturing / engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. • Investigates any deficiencies related with qualification activities and determines corrective actions. • Preparation and review of SOPs and Drawings as related to validation. • Review and approval of calibration and PM activities (e.g. schedules) and Work orders. • Preparation, execution and coordination of Cleaning Development / Verification / Validation study protocols and reports; • Preparation, execution and support of studies / risk assessments / investigations related to Cleaning • Participates in any investigations that may impact the qualified state of equipment, systems, facilities or utilities Education & Experience: • Science Degree • Minimum 2-3-year experience in Pharmaceutical Industry accredited by HPRA and FDA For more on the role call Nigel on 087 3618142 or send your CV for consideration.
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