Job Description
Team Horizon is seeking a QA Validation Specialist on a permanent basis on behalf of a global manufacturing company in the Connaught region. Why you should apply: * This is an opportunity to become an integral part of the Site Quality Assurance team and as a key member you will provide hands on technical support & oversight of Validation activities. * Opportunity for flxible & hybrid working as well as competetive salary & benefits What you will be doing: * Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk. * Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing. * Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements. * QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials. * Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility. * Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements. * Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines. * Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA * Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others. * Actively contribute to continuous improvement activities. * Other duties as assigned. What you need to apply: * Third level qualification in relevant science and/or engineering discipline * 5 years minimum experience working in a in a GMP Quality environment providing QA technical support and oversight to validation and qualification activities * Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations * Strong understanding of GMP compliance and quality standards& In-depth knowledge of quality management system (QMS) procedures and technical documentation * Excellent analytical, problem-solving, and decision-making skills * Excellent attention to detail and significant document review experience essential * Excellent technical writing skills including deviation reports and SOPs * Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail