Data Integrity Lead, Biopharma Compliance

Tandem Project Management Ltd.; Waterford; Hybrid; EUR 55,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a Data Integrity Specialist for a biopharmaceutical site in Waterford.

The role ensures data integrity is embedded in all onsite work and that Regulatory and Global Quality requirements cascade to site functions to meet all DI requirements. Responsibilities include regulatory compliance, data quality checks, training, risk assessment, CAPA, documentation, audits, and reporting on the DIMM.

Qualifications

• Relevant qualification.
• 2 years working experience in a regulated environment.

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 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.
• Establish and prioritize data integrity objectives for the site.
• Proactively identify remediation actions from findings from internal and external audits.
• Identify training needs and content for data integrity.
• Decide on corrective and preventive actions for data integrity issues.
• Is informed of any breach in data integrity.
• Advise on cross-departmental data integrity strategies.
• Is informed of inspections and audits outcome.

Job description

Tandem Project Management Ltd. is seeking a Data Integrity Specialist for a biopharmaceutical site in Waterford.

The role ensures data integrity is embedded in all onsite work and that Regulatory and Global Quality requirements cascade to site functions to meet all DI requirements. Responsibilities include regulatory compliance, data quality checks, training, risk assessment, CAPA, documentation, audits, and reporting on the DIMM.