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  • Location

    Leiden

  • Job title:

    Data Integrity Engineer

  • Sector:

    Pharmaceutical

  • Job ref:

    48409

  • Start Date:

    2022-06-07

The Company

One of the biggest pharmaceutical companies in the world focused on research and cells pharmaceutical products, medical devices, and consumer products.
Is a company that is engaged in the research and development, manufacture, and sale of a range of products in the healthcare field. It operates through three segments: Consumer, Pharmaceutical, and Medical Devices.

Role Description
 
Works within the site Data Integrity Team, specifically focusing on manufacturing and analytical systems linked to Covid-19 Vaccine production. Performs and analyses data integrity gap assessments and proposes remediations (technical, procedural, trainings), coordinating activities and stakeholders to lead to full gap remediation.
 
Responsibilities
 
- Understands both technical and procedural requirements of Data Integrity in manufacturing and analytical environment.
- Collaborates with Business System Owners, Technical System Owners, QA, and Training to identify the most efficient action to be taken for any system and at any step of the data flow.
- Analyses data integrity gaps and leads activities toward remediation.

Requirements
 
- In-depth, up-to-date knowledge of computerized systems, GMP and specifically Data Integrity practices and recent developments in this expertise area.
- Independent critical thinking and decision making to find sound solutions from a structural, regulatory, and business perspective.
- Pharmaceutical or Life Science work experience for 6+ years.

Other
Are you interested in this or another role? Do not hesitate to contact me by applying to this position.