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  • Location

    Netherlands

  • Job title:

    Data Integrity Expert (CSV)

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    48412

  • Start Date:

    2022-06-07

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.

Role Description 
As a Data Integrity Expert you will be focusing on Manufacturing and Analytical systems linked to vaccine production. You'll be performing and analyzing data integrity gap assessments and proposing remediation. 

Responsibilities
- Coordinating stakeholders and lead remediation actions to ensure that Processes and Data generated by Computerized Systems meet requirements 
Supporting and improving GMP processes related to DI topics such as Security/User Access Management, Audit Trail review, Backup & Archival 
- Performing and analysing data integrity gap assessments and leading activities toward remediation 
- Improving the procedural framework related to Data Integrity 
- Working cross-functionally with other departments and identifying more efficient actions for systems and data flow 


Requirements
- Around 3-5 years of experience in the Pharma/Life Sciences industry
- Knowledge on computerized systems and GMP
- Experienced performing gap assessments/gap identification 
- CSV experience is a big plus 
- QA background is an advantage 


Other Information 
For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or apply directly below.