Ensure that all established cGMP schedules and systems are maintained, documented as per ALCOA + and are adhered to
Ensure that equipment is cleaned, maintained and calibrated, and that Production Area/Facility cleaning and housekeeping are performed as per SOP
Undertake and supervise the execution of manufacturing activities as per BMR and in accordance with the approved SOPs, EHS and... regulatory guidelines
Maintain inventory of required tools, spares and PPM, equipment reviews on manufacturing equipment to ensure that down time is minimized
Support initiatives for data integrity and normalization by developing structures to monitor and check on data collected against set standards
Keep abreast of current data development and management trends within manufacturing systems and technology to maintain personal skills/knowledge base to deliver leading-edge solutions to the various departments needs
Analyse and present Operational Excellence reports such as OEE, Cycle times, Performance & Utilization (Capacity, Area & Direct Labouré Utilization) at the different assigned manufacturing areas, Yield/Output Management, Breakdown Management
Perform DILO studies, track and execute recommendations to ensure continuous improvement
Carry out investigations to establish root causes and effective CAPA to enable adherence to the established Quality Management Systems
Any other assignments allocated by Line Manager
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  • Engineering