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 flexible & hybrid working as well as competitive 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 ongoing 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 SOPs/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, multi-department 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 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, troubleshooting skills and excellent attention to detail.
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