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QA Specialist
Position Summary 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. This includes supporting batch release activities, ensuring adherence to GxP standards, and upholding Quality expectations across all quality and operational processes. The role also involves day-to-day QA activities and providing routine support to production operations and other departments to ensure compliant and efficient workflow. This is a 100% on-site role requiring attention to detail, and hands-on QA support across all IMP production activities.
Essential Functions 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.
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Education and Experience Bachelor’s degree in scientific or related discipline. Minimum 3 years of experience in a GMP-regulated QA environment. Experience in GMP manufacturing, batch release, and QMS management is essential.
Knowledge, Skills, and Abilities In-depth knowledge of GMP, GCP, and clinical trial regulations. Strong understanding of IMP requirements and QP release processes. Experienced in handling deviations, CAPAs, and change controls. Excellent written and verbal communication skills. Highly organised with strong attention to detail. Able to work effectively under pressure and manage multiple priorities. Proficient in electronic QMS and document management systems. Proactive, self-motivated, and team-oriented. Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
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Travel Requirements Occasional travel may be required for training or audit activities (<10%)
Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. Regularly required to walk within production and laboratory areas. May be required to stand for extended periods. Exposure to cleanroom environments and temperature-controlled zones.
Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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