Functieomschrijving
For our client, we are looking for a
Metrology-EMS Specialist who supports the daily management of the Metrology & EMS division, Validations / Qualification of facilities, equipment and infrastructure.
More generally, he/she ensures that the services offered by the Facilities Department always fulfill the level of quality required. He/she should also make sure the operational departments focus on their core business.
As a Metrology-EMS Specialist, you will :
- Be responsible for all aspects of Metrology & EMS, CMMS, maintenance of production equipment within the Facilities department ;
- Be responsible for the organization, prioritization and distribution of tasks of the Metrology and EMS division within the Facilities Department ;
- Maintain a close relationship with operational departments to provide support and meet their needs ;
- Collaborate with the Management to address, find and solve any problems occurring on the equipment ;
- Define a planning for maintenance and monitoring of equipment / production facilities and of environmental monitoring system (follow-up and implementation internally, or via subcontractors) ;
- Write/Review documents, URS, IQ/OQ/PQ of new installations and ensure the qualifications/validations of those installations ;
- Provide support to operational departments in terms of qualification and validation both annually and for new systems, equipment or infrastructure in line with our quality standards and GxP regulations ;
- Collaborate with the Quality and Operations departments to ensure compliance / write SOPs, WI, and all other documents necessary to perform annual monitoring of equipment/system and installation within his/her areas of responsibility ;
- Support corrective maintenance, CAPA, MOC associated within his/her areas of responsibility in a timely manner ;
- Ensure document monitoring and classification of equipment/systems or infrastructures within his/her areas of responsibility ;
- Manage and update the database ;
- Come up with solutions to improve processes and performance of our systems/equipment ;
- Review and approval of calibration certificates and validation documentation.
ProfielExperience- Experience in metrology, validation, qualification ;
- Experience of the working environment and experience of standards specific to the Pharmaceutical Industry (GxP) ;
- Knowledge of ventilation standards, filtration of clean rooms (asset).
Education- Education in Metrology or equivalent by experience.
Skills and Attributes- Pharmaceutical Industry and Bio-Tech. ;
- GMP, GLP, GDP ... ;
- Capacity for analysis and synthesis ;
- Organizational and planning skills ;
- Good ability to respond and adapt to change ;
- Good ability to cope with unforeseen events ;
- Written skills in English.
Computer Skills- Good ability to learn new software ;
- MS Office and more specifically Excel (VBA, Script and macro).
Organisatie- en afdelingomschrijving
Our client located in Louvain-la-Neuve is a company active in the pharmaceutical sector.
Aanbod
Our client offer :
- A permanent contract in a great company ;
- A challenging position in a company where the work life balance is a real concern ;
- A competitive salary with extra-legal benefits.
Interested? In order to process all applications as quickly as possible, please apply directly via our website : www.select-jobs.be. Your application will then be immediately linked to the correct vacancy and your data will be included in our database for future opportunities.