Data Integrity Pro – Specialist/Manager (Waterford)

Sanofi; Waterford; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Sanofi in Waterford, Ireland is recruiting Data Integrity Experts at multiple levels to join the Quality Systems team. The role focuses on embedding data integrity into daily operations and site-wide compliance, with interviews starting imminently.

Based in Waterford, you will help translate regulatory standards into practical working practices, lead data quality checks, trainings, and CAPA actions, and participate in regulatory inspections and audits as needed.

Qualifications

• Focus on data integrity across regulatory requirements.
• Develop and deliver data integrity training programs.
• Lead risk assessments and CAPA for data issues.
• Ensure proper documentation practices and data recording.

Responsabilités

• Ensuring compliance with regulatory requirements and company policies related to data integrity
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue
• Developing and delivering training programs on data integrity principles and practices
• Identifying and assessing risks related to data integrity and implementing mitigation strategies
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)
• Leading continuous improvement initiatives to enhance data integrity practices
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication

Connaissances

Data integrity

Regulatory compliance

Data quality checks

Training delivery

Risk assessment

CAPA

Documentation

Data validation

Continuous improvement

Regulatory inspections

Description du poste

Sanofi in Waterford, Ireland is recruiting Data Integrity Experts at multiple levels to join the Quality Systems team. The role focuses on embedding data integrity into daily operations and site-wide compliance, with interviews starting imminently.

Based in Waterford, you will help translate regulatory standards into practical working practices, lead data quality checks, trainings, and CAPA actions, and participate in regulatory inspections and audits as needed.