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Equipment and Stock Management Associate Niel Belgium,  

ETheRNA (company)

Posted on : 11 June 2017

Project Description

Job Description
  • The Equipment- and Stock Management Associate will be the technical owner of the clean room 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:

Technical Owner Equipment:
  • Responsible for compliant status of Equipment (this includes clean room 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 company 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 the company  is adhered for services on Equipment (this include clean room 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. 

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: 
           o Full Life Cycle management for equipment, used in a regulated environment;
           o Good knowledge in speaking and writing of Dutch and English;

           o Certifications:
                - Annual exposure to scientific meetings, Workshops, Seminars and Congress (desirable);
                - Project management, e.g. Flawless Project Execution;
                - Health, Safety & Environment trainings (when applicable);
                - Business Conduct trainings (when applicable).

            o Training:
                - Applicable regulatory and compliance requirements (including but not limited to GMP and GxPs ):
                      " company policies, procedures;
                      " Applicable corporate and local environmental, health, and safety requirements.
                - company procedural documents related to assigned job responsibilities:
                      "A personal role and task based training plan;
                      "Root Cause Analysis (RCA).
                - Technical topics related to performance of assigned tasks:
                      "Technical knowledge on company  Equipment.
  • Other Qualifications, Skills and Abilities:
           o Quality minded, rigorous, autonomous and customer oriented;
           o Ability to foster teamwork and a collaborative atmosphere;
           o Communicative;
           o Well organized, well-structured, hands-on, result focused;
           o Enthusiastic, flexible and able to multitask;
           o Ability to set priorities and take initiative;
           o Knowledge of MS Office (Excel, Word, PowerPoint, Outlook). 

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development; 
  • Employment contract of unlimited duration with a competitive salary package. 


2845 Niel Belgium

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