Data Integrity Specialist

Data Integrity Specialist - 12 month contract with a Waterford based pharmaceutical client. 3 days onsite, 2 days remote.

Responsibilities

• 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 issues
• 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

Qualifications

• Must hold a qualification in a scientific or technical discipline
• 2-5 years experience within a GMP environment