TEMP PRINCIPAL QA VALIDATION SPECIALIST required by CareerWise Recruitment for our BioTech client in Limerick, 12 month Temp contract on offer.
The TEMP PRINCIPAL QA VALIDATION SPECIALIST will Validate / Qualify equipment, systems and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
Role of this position
Generates, executes and / or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and / or improvements.
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
Reviews, edits and approves change controls, SOPs, reports and other documentation
May supervise, provide direction and assign work to Validations Specialists and / or contingent workers to meet goals and deadlines.
Manage and drives projects and prepares status reports.
May present at both internal and external (regulatory) audits
Stays current with industry trends, regulatory requirement updates, and communicating same to team
May manage full time employees and / or contingent workers.
Some travel may be required.
BS / BA in Engineering, Chemistry, or Life Sciences.
8+ years of related experience within the field preferred; may substitute relevant experience for education.