AVI Operator

To operate, monitor, adjust, and maintain the Automatic Visual Inspection (AVI) machine to ensure sterile products are inspected accurately and consistently in accordance with Good Manufacturing Practices (GMP), approved Standard Operating Procedures (SOPs), and company quality standards. TECHNICAL SKILLS Operation and adjustment of Automatic Visual Inspection (AVI) equipment. Principles of automated visual inspection for sterile ampoules and vials. Identification of critical defects, including visible particles, glass defects (cracks, chips and checks), cosmetic defects, fill volume abnormalities, and stopper or seal defects where applicable. Inspection recipes, machine settings, product changeovers, and verification procedures. Basic troubleshooting of sensors, cameras, conveyors, reject stations, and other AVI system components In-process controls (IPCs) and inspection verification requirements IInterpretation of machine alarms and implementation of appropriate corrective action. Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and data integrity (ALCOA+) principles. Batch record completion, traceability requirements, and line clearance procedures Overall Equipment Effectiveness (OEE), downtime recording, reject trend monitoring, and basic statistical process control. Cleaning, sanitisation, and autonomous maintenance requirements for AVI equipment Health, Safety, and Environmental (HSE) requirements applicable to sterile manufacturing. Contamination control and cleanroom behaviour. Deviation reporting, non-conformance management, and Corrective and Preventive Action (CAPA) processes. Regulatory expectations relating to the visual inspection of sterile injectable products, Camera calibration and verification procedures. Vision system software operation and recipe management. Challenge set testing and inspection qualification. Root cause analysis of reject trends Lean manufacturing and continuous improvement principles. Familiarity with PIC/S, EU GMP Annex 1, FDA, and WHO requirements for sterile pharmaceutical manufacturing. Excellent attention to detail. Good visual acuity and colour discrimination. Mechanical aptitude and technical troubleshooting ability. Good communication and teamwork skills. Ability to work under pressure and meet production targets. Time management and organisational skills. Strong commitment to quality and compliance. Machine Operation: Operate the AVI machine in accordance with approved SOPs and batch documentation. Perform machine setup, product changeovers, and start-up checks; select and verify the correct inspection recipe and machine parameters before production; monitor machine performance and make approved adjustments to optimise inspection efficiency and minimise unnecessary rejects; respond to machine alarms and perform first-line troubleshooting where appropriate. Escalate equipment faults to the Production Supervisor or Engineering Department. Inspection Activities: Ensure all units are inspected for visible particulate matter, cosmetic defects, container defects, and fill volume abnormalities; verify reject mechanisms are functioning correctly; conduct routine challenge tests and inspection verification checks as per procedures; monitor reject trends and report abnormal rejection rates for investigation; segregate and account for rejected products in accordance with approved procedures. Documentation: Complete batch manufacturing records accurately and in real time; record production outputs, rejects, downtime, machine interventions, and line clearance activities; complete equipment logbooks, cleaning records, and inspection verification documentation; ensure compliance with Good Documentation Practices (GDP) and data integrity (ALCOA+) principles. Quality & Compliance: Comply with GMP, GDP, company procedures, and regulatory requirements; participate in line clearance activities before and after production; report deviations, nonconformances, equipment malfunctions, and quality concerns immediately; assist with investigations, CAPAs, and continuous improvement initiatives where required; maintain product traceability throughout the inspection process. Equipment Care: Perform routine cleaning and sanitisation of the AVI equipment and work area; conduct basic autonomous maintenance, including inspection and reporting of abnormalities; assist Engineering during preventive maintenance, validation, and qualification activities