Data Integrity Specialists

3 x Data Integrity Specialists are needed at Wallace Myers to work on contract at our Global Biopharma client's site in Waterford.

Contact Jenn Dinan on or email.

Contract Type: Ltd contracts
Duration: 12 months

Job Purpose

The aim of the role is to ensure that Data Integrity is embedded in all aspects of work performed in Waterford and that Regulatory and Global Quality requirements are cascaded to site functions to ensure that all Data Integrity requirements are met.

Main Accountabilities

• 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
• Establishing and prioritizing data integrity objectives for the site
• Proactively identifying remediation actions from findings from internal and external audits
• Identifying training needs and content for data integrity
• Deciding on corrective and preventive actions for data integrity issues
• Being informed of any breach in data integrity
• Advising on cross-departmental data integrity strategies
• Being informed of inspections and audits outcomes

All applications will be treated with the strictest of confidence.