argenx

Senior IT Quality Specialist

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As an instrumental part of the BIS team, the Senior IT Quality Specialist will work closely with the BIS IT Quality & Validation team with the implementation of GxP and non-GxP systems across the organization. The Senior IT Quality Specialist will lead and collaborate on IT Quality projects to implement, change or upgrade CS systems and processes.

We are looking to fill in this position through consultancy. Please note that weekly travel to the office in Ghent, Belgium, is needed.

Roles And Responsibilities
  • Lead or collaborate on IT Quality projects to implement, change or upgrade CS systems and processes
  • Support local BIS Leads as Subject Matter Expert and provide global guidance
  • Create, review and manage the designated System Deliverables and/or validation deliverables
  • Support GxP-determination and validation activities for global CS systems
  • Evaluate, test, and validate software and CS services Support the creation of system, ITSM SOPs as author, reviewer, or expert
  • Analyze deficiencies in service or performance and recommend product or service improvements to address problems Ensure computerized systems comply with applicable GxP, regulatory and corporate requirements throughout the life cycle of the systems
  • Designs and implements defect reduction programs

Skills And Competencies
  • Excellent knowledge of different Software Development Life Cycle (SDLC) methodologies (Agile, DEVOPS, Industry IT Quality best practices, Computer Systems Validation, good understanding of ITIL
  • Good knowledge of CGMP and specific regulations and guidelines applicable to computerized systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11....) and other regulations ex HIPAA & GDPR
  • Knowledge of relevant scientific discipline or equivalent through education and experience
  • Team player with strong communication skills
  • Quality-minded individual who is accurate in execution and reporting

Education, Experience And Qualifications
  • Bachelors degree in (Computer) Sciences or Biological Engineering or equivalent preferred
  • 5-7 years of experience in computer systems validation / IT Quality
  • Experience with implementation of GxP and non-GxP systems

Offer
  • A competitive salary package with benefits such as a company car
  • A work environment in a human-sized, dynamic, rapidly growing biotech company
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