Data Integrity Specialist

Posted 8 days 19 hours ago by Careerwise Recruitment

Permanent
Full Time
Other
Waterford, Ireland
Job Description

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