QA Validation Specialist

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