Position Details
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.
Principle 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
Education /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