Position Details

The QA Associate (Document Control) is an integral part of our Manufacturing team based out of our Ireland - Sligo site.  

Responsible for delivery of quality assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in QA. This key role involves collaboration with other departments such as Quality Control, Manufacturing, Engineering and Technical Services. 

Key Responsibilities:
•    Manage the GxP Document Management system as per site procedures 
•    Manage the Training Management system as per site procedures 
•    Support and/or manage assigned areas of the Quality Management System (QMS) including Deviation, Change Control and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval and release of production materials. 
•    Generate, review, and approve SOP's/other documentation as applicable to your area of responsibility to ensure compliance with GMP and regulatory requirements. 
•    Manage the reference and retention sample program 
•    QC Support including review and approval of QC testing documentation 
•    Issuance and retrieval of batch records and protocols, logbooks 
•    Review and approval of Batch Processing Records 
•    Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures. 
•    Support QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others 
•    Support audits and inspections 
•    Actively contribute to continuous improvement activities 
•    Other duties as assigned 

Job Specific Technical, Functional and Professional Competencies:
•    Strong understanding of GMP compliance and quality standards 
•    Excellent attention to detail and significant document review experience essential 
•    Excellent technical writing skills including deviation reports and SOPs 
•    Effective time management and multi-tasking skills 
•    Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail 
•    Excellent communication skills, both verbal & written. 
•    Proficient in written and spoken English 
•    Collaborative Team Player 

Essential Education and Experience:
Third level qualification in a Biological/Pharmaceutical science discipline with a minimum of 3 years’ experience working in a in a GMP Quality Environment