Data Integrity Specialist

About the Role

CareerWise Recruitment is seeking a Data Integrity Specialist for a 12-month contract supporting a pharmaceutical client based in Waterford. This hybrid role requires onsite presence three days per week and remote work for two days. The ideal candidate will have experience managing CAPAs, validated computerized systems (CSV), and driving continuous improvements in data integrity practices.

Key Responsibilities

• Ensure compliance with applicable regulatory standards and internal policies regarding data integrity.
• Perform routine data quality checks and validations to identify and resolve data integrity issues.
• Design and deliver training sessions focused on principles and best practices of data integrity.
• Identify data integrity risks and implement mitigation plans.
• Maintain proper documentation protocols for data recording, storage, and retrieval.
• Investigate data breaches or potential falsification incidents and manage corrective and preventive actions (CAPA).
• Lead continuous improvement projects to strengthen data integrity processes.
• Oversee validation of computerized systems ensuring adherence to data integrity requirements.
• Prepare for and participate in regulatory inspections and audits related to data integrity.
• Generate and analyze data integrity reports including DIMM (Data Integrity Maturity Model) metrics for management review.
• Represent the site in global Communities of Practice (CoP) and, if requested, engage with the Centre of Excellence (CoE) ensuring effective local communication.
• Set and prioritize data integrity goals at the site level.
• Proactively address remediation actions arising from internal and external audit findings.
• Identify and develop training needs and content targeting data integrity.
• Decide on corrective and preventive actions in response to data integrity challenges.

Candidate Requirements

• Degree or qualification in a scientific or technical discipline.
• Between 2 and 5 years of professional experience in a GMP-regulated environment.

Additional Information

Interested candidates may contact Louise Mulligan at CareerWise Recruitment for further details. CareerWise Recruitment, established in 1999, specializes in management and technical recruitment across life sciences, ICT, engineering, food, and agriculture sectors across Ireland.

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