Metrology Expert (SME)
- Master's Degree
- Ideally 5 years' experience in the pharmaceutical metier with experience in metrology.
- Good knowledge of international standards (CFR, Eudralex, ISO norms, ...) and GMP.
- Good knowledge of French and English (written and spoken)
- Strong ability to adapt to change, work under pressure; prioritize these activities, motivated, enterprising and proactive.
Job purpose :
The SME Calibration is a Belgian sites expert for the calibration of the production measurement equipment/probe and for the MPU measurement team equipment. This expertise covers the validation, requalification, calibration, maintenance and reliability of this equipment. He must know the use of this equipment in production processes.
The SME Calibration supports the units of GSK Vaccines Belgium (MPU, SPU, CQC, R & D): transversal and local analysis for general and specific problems.
The SME Calibration defines the maintenance, metrology and validation strategies, develops and ensures the maintenance of the associated documentary system and ensures deployment on the Belgian sites.
The SME Calibration masters the quality systems tools (deviation, change control, CAPA, inspections, quality governance ...); he works closely with the Maintenance, Validation and C & M Site System Managers (SSM) in the process of the System Effectiveness Review (SER) and transversal projects relating to his expertise area.
Key responsabilities :
For his expertise area, the SME is in charge of:
- To maintain up-to-date knowledge of regulatory / regulatory requirements and QMS standards and assess their potential impact on existing systems.
- He is an actor in the Quality Regulatory Intelligence (QRI) process.
- Creating and interacting with LSPOCs to conduct a GAP analysis against QMS standards (new or revised) : evaluation and documentation of the "In Place" activities.
- To pull up the GAP / risks and resources required by the Quality Council to ensure the "In Use" activities.
- To establish and transmits an annual report for his expertise area based on KPI, deviations generated related to maintenance, validation and C & M activities by analyzing root causes.
- To carry out transversal assessments relating to his expertise area to verify the "In Use" (participate in transversal audits).
- To define and manage appropriate action plans.
- To define and manage his own documentary system. Write the procedures (LSOP, WKI, appendices) relating to his expertise area and update all related documents : GAP Analysis, GAP assessment, periodic review, checklists, e-Checklists, modification of TLE (Task List Equipment ) forms. He must ensure the applicability of these documents via his LSPOCs network.
- To manage and / or follow up of the Master Data's modifications linked to transversal projects (like procedures modifications, ...).
- To train staff on the release of a new version of these LSOP / WKI , coach qualifiers to the qualifications of the personnel related to these revisions.
- To introduce the LSOP / WKI to the authorities during inspections.
- To facilitate the exchange of knowledge and the sharing of good practices through his LSPOCs network.
- To define and transmit to users the criteria for replacement of the sensors, the standard life of the parts and / or equipment relating to his expertise area (obsolescence management).
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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