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QA Engineer IT Qualification & Validation - Belgium  

Biocartis (company)


Posted on : 12 March 2017

Project Description


Purpose of the position 
  • Validating and maintaining the validated state of IT Applications and IT Infrastructure. 

  

Tasks/outcome domains 

Ownership of the IT Applications SOP & IT Application Validation Master Plan 
  • Planning and follow-up the validation of IT Applications 
  • GxP criticality & 21CFR Part11 assessment of IT applications 
  • Gathering of user requirements & process descriptions from process owners 
  • Support application owners in writing specification documentation 
  • Writing of qualification protocols & review of qualification reports 
  • Guiding process owners in creation of Work Instructions for IT Applications intended use 
  • Support training of Work Instructions for IT Applications intended use  
  

Ownership of the IT Infrastructure SOP & IT Infrastructure Validation Master Plan 
  • Planning and follow-up the validation of IT Infrastructure 
  • GxP criticality assessment of IT infrastructure 
  • Identification of infrastructure needs together with application owners and infrastructure owners 
  • Writing of qualification protocols & review of qualification reports 
  • Guiding infrastructure owners in creation of Work Instructions for installation, backup, restore & disaster recovery  
  

Profile 
  • Master or Bachelor in a relevant technical area, e.g. software engineering, chemical engineering, bio-chemistry or you have achieved a similar level by experience 
  • Preferably 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry 
  • Familiar with following 21 CFR 11 Electronic records & signatures and 21 CFR 820 Quality System Regulation 
  • Familiar with following harmonized standards: ISO 13485 QMS Medical Devices; ISO 14971 Risk Management Medical Devices 
  • Familiar with following guidance: GAMP 5; GAMP IT Infrastructure and control; AAMI TIR36:2007 Validation of software for regulated processes 
  • Familiar with Agile Software development 
  • Familiar with Change Control and Configuration Management21 CFR 820 Quality System Regulation 
  • Result oriented and driven 
  • Team player and eager to learn 
  • Flexible and pro-active mindset 
  • Can work autonomously 
  • Well-developed interpersonal skills 
  • Analytical mindset 
  • Excellent knowledge of English, both spoken and in writing.  Good knowledge Dutch is a strong asset. 
  • MS Office 
  • Project specific Applications; e.g. ERP, LIMS,..  
  


Our offering 
  • We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. 
  • You can be part of a very dynamic, young and growing team in a highly innovative environment. 
  • You will have freedom to shape your work and shape your job. Your input is highly appreciated. 


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