Equipment and Stock Management Associate - Belgium
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- 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
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.
- 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,…).
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.
o Full Life Cycle management for equipment, used in a regulated environment;
o Good knowledge in speaking and writing of Dutch and English;
- 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).
- 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 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.