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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Data Integrity Steward

OUR NEED:

The data integrity steward is responsible for operational coordination and implementation of processes necessary to ensure data integrity, data management and data security.  Based on the Guerbet document system and in particular the documents associated with the Laboratory Computer Systems (IS), the data steward's mission will be to contribute to the governance, quality and integrity of the data and metadata managed with the Laboratory IS throughout their life cycle.

 

YOUR ROLE:

  1. Contribute to the application of Guerbet global governance on data integrity.
  2. Control and minimize risks to data integrity.
  3. Set up and pilot (in conjunction with the Committees in charge of governance / maintains laboratory IS operating conditions) indicators on data integrity.
  4. Develop action plans to remediate failures associated with the principles of data integrity.
  5. Identify, create and implement new DI standards, implementation plan and training strategy
  6. Advance the DI strategy and raise awareness of documentation standards and appropriate system requirements, while increasing understanding of how to appropriately address DI situations
  7. Provide cGMP and Data Integrity coaching to site to ensure compliance with data lifecycle and performance requirements to achieve DI strategy
  8. If applicable, verify that the backup/restore and archiving processes are operational.
  9. Maintain the list of rights assigned per user.
  10. Ensure that people accessing the Laboratory IS have the appropriate training and authorizations.
  11. Participate in the verification of the maintenance of the "validated" state of the Laboratory IS.
  12. Conduct internal audits related to data integrity
  13. Ensure periodic reviews are conducted.
  14. Participate in audit trail reviews.
  15. Participate in impact studies and risk analyses when updating the laboratory IS or changing processes (in accordance with the MDC Guerbet).

 

YOUR BACKGROUND:

 

Education required/ preferred:

BA/BS in related science or business field plus 5 years of experience in the pharmaceutical industry.

 

 

Preferred Skills/Qualifications:

Good interpersonal and verbal/written communication skills; able to use a computer for data analysis

Skills/Competencies:

Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA, and pharmacopeia requirements

Other Skills:

Effective communication with both team members and other plant support groups

 

YOUR PROFILE:

  • Position reports to the Quality Systems Manager
  • Routinely interfaces with various personnel from all site departments
  • Receives assignments from manager, but exercises initiative in setting priorities within a prescribed framework of tasks.  Sets and acts upon priority requirements with minimal supervision. 
  • Possesses personal responsibility as needed to provide support to both internal and external customers.