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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