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The post holder undertakes the coordination and prioritisation of workload to ensure efficient service delivery and the repackaging and over‑labelling of a variety of medicinal products, medical devices and other items. The work is carried out in accordance with Standard Operating Procedures (SOPs) designed to comply with the principles of current Good Manufacturing Practice (cGMP).
Good Manufacturing Practice/Regulatory/Quality • Prioritises and schedules batch creation in the correct sequence, using computer systems to assess workload, deadlines and operational requirements. • Undertakes the repackaging and over labelling of a wide range of pharmaceutical products in compliance with all local procedures and the principles of current Good Manufacturing Practice (cGMP). • Reports any quality deviations identified during routine duties to the Section Head. • Assists with the completion of corrective and preventive actions (CAPAs) arising from QIRs and QERs within agreed timeframes. • Assists with remedial actions within the section following regulatory inspections by the MHRA and internal audits, ensuring completion within the specified timescales. • Complies with Health & Safety and COSHH regulations within the section. • Assists in maintaining manufacturing cleanrooms and related equipment to the required standards. • Accurately completes all required documentation, including batch manufacturing records, cleaning logs, equipment logs, and environmental monitoring forms. • Consistently meets set targets and contributes to the achievement of departmental objectives.