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R&D Quality & Compliance Officer Mechelen Belgium,  

Galapagos (company)


Posted on : 11 May 2017

Project Description

Description:
  • The R&D Quality & Compliance Officer will act as the Quality Management System (QMS) System Expert  and will be responsible for managing the day-to-day support activities for the global R&D Quality & Compliance group, with an extensive focus on managing and maintaining the QMS. 
  • As an R&D Quality & Compliance Officer, you will be responsible for: QMS Procedural Document (ProcDoc) Management: 
  • Maintain the QMS ProcDoc module for global R&D (i.e. create main document sets, ensure templates are populated using correct styles, activate and supervise workflow status, create necessary reports to adequately follow up ProcDoc statuses)  


QMS Learning Management System: 
  • Maintain the QMS LMS module for global R&D (i.e. role based, training session management, run pre-defined metrics reports on training attendance rate, &)
  • Guide & support local training coordinators in managing individual training sessions  



QMS Audit / CAPA Management: 
  • Maintain the QMS Auditing module (current audit findings database) to run pre-defined metrics reports on audit observations and CAPAs for global R&D. 
  • Generate metrics supporting the quarterly board reporting activities
  • Populate the GLPG Document Management System with the Audit Certificates where appropriate
  • Populate CAPA components in QMS Auditing Module and ensure proper filing of audit / CAPA documentation.   



Administrative tasks: 
  • Manage daily support to R&D Quality & Compliance group: agenda management, travel coordination, expense notes, etc &
  • Coordinate Records Retention activities by supporting the R&D business partners in view of off-site archiving activities, records clean-out activities, etc &  
  


Requirements 
Education Bachelor s degree in a business / healthcare administration or equivalent experience in a related field, with multilingual qualifications or proven experience.   Experience A minimum of 5 years in coordinating role, preferably in an international environment.   



General Skills  
  • Quality minded
  • Precise and accurate
  • System minded
  • Excellent MS Office skills (MS Word, Excel, Powerpoint, &)
  • Strong SharePoint knowledge
  • Strong organization skills
  • High degree of flexibility
  • Assertiveness and excellent communication skills
  • Analytical thinking
  • Problem solving  

Locations

Mechelen Belgium

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