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Equipment and Stock Management Associate Niel Belgium,  

Posted on : 11 June 2017

Project Description

General Job Description The Equipment- and Stock Management Associate will be the technical owner of the cleanroom installation and the production, QC and Immuno-monitoring lab equipment. The equipment- and stock management associate will work in close collaboration with the Production Lead and his team. This position reports into the Production Lead. Responsibilities and Duties The Equipment and Stock Management Associate duties shall include, but not be limited to: 1. Technical Owner Equipment: Responsible for compliant status of Eguipment (this includes cleanroom installation, production, QC and other lab equipment), and manage maintenance/(re-)validation and calibration planned on time internal or with outsourced external partners; Process owner for the eTheRNA QMS procedural documents related to Equipment management, including Equipment Maintenance and Calibration strategies. (Standard Operating Procedures (SOPs), &); The Technical Owner will review and asses at least monthly the instrument and equipment maintenance and function check records (calibrations, maintenance and other interventions on Equipment); Ensure the Quality Management System (QMS) of eTheRNA is adhered for services on Equipment (this include cleanroom installation, production, QC and other lab equipment); Act as point of contact spokesperson for management of Equipment during internal and external audits; Provide technical input, review and approve Equipment Qualification documents for new or changed Equipment. (Equipment Requirements Specifications, IQ-OQ and PQ Test Documentation,...); Manage Change Controls, related to Equipment; Manage Deviations and Changes related to Equipment e.g. if any procedure and/or policy has not been followed, if Equipment deviate from the established specifications. Execute and implement appropriate corrections, corrective actions and/or preventive actions and document Root Cause Analysis, if required; Execute and implement appropriate corrections, corrective actions and/or preventive actions (CAPA s) and document Root Cause Analysis, if required; Assures/Performs adequate document filing for Record Retention; Keep track on equipment manuals and spare parts; Monitors key process indicators (KPIs) for the management of Equipment and take action when the KPIs are not met; Ensure appropriate controls and procedures are adhered to ensure reliable data are generated; Acts as Project Leader/Team Member of new projects were equipment is involved; Ensure to have an up to date Job Description, Curriculum Vitae and Training Records. 2. Stock management: Inventory/stock management (overseeing and controlling of the receipt, registration, storage & release of products ordered) for materials used in production/QC and Immunomonitoring laboratory; Maintenance of supplier certificates for materials used in the production/QC and IM laboratory; Overseeing the stock and make adequate inventory to order stock materials on time; Organize the stock with regards to good stock management principles (e.g. FIFO, KANBAN principle, &). Job Requirements Education: Bachelor in Sciences with 4 years of relevant experience, Master in Sciences or Industrial Engineering with 2 years relevant experience or Equivalent by a combination of education and relevant experience. Experience:


2845 Niel Belgium

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