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