Data Integrity Specialist

Position Overview

We are seeking a Data Integrity Specialist for a 12-month contractual role based in Waterford with a pharmaceutical client. The role requires working onsite three days per week and remotely for two days. Ideal candidates will have experience managing CAPAs, overseeing computerized system validations, and driving continuous improvements in data integrity standards.

Key Responsibilities

• Ensure adherence to regulatory and company data integrity standards.
• Perform regular data quality reviews and validations to detect and resolve any integrity issues.
• Design and deliver training programs focused on data integrity principles and best practices.
• Identify risks related to data integrity and implement effective mitigation measures.
• Maintain accurate documentation practices, encompassing data recording, storage, and access.
• Investigate incidents involving data breaches or falsification and execute corrective and preventative actions (CAPA).
• Lead initiatives aimed at enhancing data integrity processes continuously.
• Supervise validation of computerized systems to ensure compliance with data integrity requirements.
• Prepare for and engage in regulatory inspections and audits regarding data integrity.
• Generate and analyze data integrity metrics and reports, including the Data Integrity Maturity Model (DIMM).
• Act as site representative in the Community of Practice (CoP) led globally and participate in the Centre of Excellence (CoE) as needed, ensuring effective local communication.
• Set and prioritize data integrity goals at the site level.
• Proactively identify and address remediation needs arising from audit findings.
• Determine training requirements and curricular content related to data integrity.
• Make decisions on corrective and preventive measures for data integrity challenges.

Candidate Requirements

• Possess academic qualifications in a scientific or technical field.
• Have between 2 and 5 years of experience working within a Good Manufacturing Practice (GMP) environment.

Additional Information

For more details, please contact the recruitment consultant directly.

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