QA Specialist

The QA Specialist is responsible for maintaining and continuously improving the site's Quality Systems to ensure full compliance with GLP, GMP, and MHRA regulatory requirements.

Requirements

• Oversee day-to-day QA activities associated with IMP manufacturing
• Provide quality oversight for batch record review, line clearances, and approval of manufacturing and packaging documentation
• Review and approve deviations, CAPAs, change controls, OOS/OOT, and audit observations
• Lead internal audits and support external and regulatory audits to ensure compliance with GxP (GMP and GLP) and other applicable standards
• Approve or reject starting materials, packaging components, and finished products
• Maintain and continuously improve the Quality Management System (QMS)
• Maintain current regulatory knowledge, communicating information and updates to staff as appropriate
• Review and issue SOPs and QA-related documentation in the electronic QMS
• Ensure proper QA documentation is archived in line with GLP/GMP expectations
• Support training and implementation of GxP-compliant procedures
• Audit raw data (and associated study documentation where appropriate) to ensure that the work has been completed to GxP
• Interface with cross-functional teams including Manufacturing, QC, Project Management, Regulatory Affairs, and Supply Chain
• Ensure compliance with clinical trial regulations and IMP labelling and documentation requirements
• Provide support for QP release preparation and documentation review
• Act as the GLP Archivist, ensuring all study records, documentation, and associated materials are archived, maintained, and retrieved in accordance with GLP, MHRA, and internal quality requirements, while supporting audits and inspections as needed
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management