Connecting...

Quality Assurance - CSV

Location: Boxmeer, North Brabant Salary: €5000 - €7000 per month + competitive
Sector: Life Sciences Type: Contract

Quality Assurance - CSV

Are you an IT oriented QA Specialist with experience of Computer System Validation's of laboratories? A client in Boxmeer is looking for an Engineer.

Responsibilities:

  • Classification of Computerized laboratory systems
  • Reviewing and writing qualification documents (URS, protocols / reports, etc.)
  • Close contact with the internal customers; Verification of qualification documents produced by outside companies.

The Main goal of the position is to support the backlog remediation of SDLC Validation of the R&D Laboratory systems

  • Writing QA Plans
  • Setting up the requirement specification together with the Subject Matter Expert
  • Writing QA summary reports
  • Writing Installation document, configuration specification & documentation index.
  • General SDLC Documentation: Traceability Matrix - Configuration Specification
  • Support operational processes such as Change control and Periodic reviews

Details

  • start date: Negotiable
  • Start with a year contract; with the aim on extension

Skills

  • Bachelor/Academic degree in life sciences or IT (Biotechnology or related) or comparable level through experience;
  • Computer System validation experience, in a GxP environment.
  • Experience with: 21CFRpart11 - GAMP - SDLC
  • Strong communicator and ability to build bridges between groups and organizations.
  • Ability to create a team spirit;
  • Knowledge of GxP guidelines and global validation expectations;
  • Passion for Lean and Continuous Improvement;
  • Customer focused, process oriented and data driven;
  • Good command of writing and speaking in English and Dutch.