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Data Intergrity/CSV Specialist

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Location Leiden, South Holland Salary Negotiable
Sector Life Sciences Type Permanent

CSV / Data Integrity Specialist

We are looking for a technical writer working for process automation systems. You will implements changes to system documentation, following the analysis of data integrity gap assessments, this includes security, periodic review SOP's, system design etc. You will execute and reports periodic reviews of process automation and IT systems according to predefined processes. In these projects, you will become competent in the use of an electronic documentation management systems (EDMS). Together with the DI SME(subject matter expert) you will offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners.

Principal responsibilities:

  • Write and revise site & system SOP's to include data integrity requirements
  • Analyse data integrity gap analysis results, propose and execute remediation actions
  • Guides Business and Technical System Owners in current expectation of Data Integrity
  • Understands both technical and procedural requirements of Data Integrity
  • Familiar with production systems: PLC / HMI / SCADA / MES & standalone systems such as filter integrity testers
  • Manages work according to a schedule The focus of the function is to execute remediation actions that ensure that the Computerized Quality Systems meet the current requirements of Data Integrity. The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions. Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.

Requirements & Minimum experience:

  • 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 - GAMP5 - SDLC - Data Integrity
  • 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.