Data Integrity Specialist

Tandem Project Management Ltd.; Munster; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Tandem Project Management Ltd. in Waterford seeks a Data Integrity Specialist to ensure Data Integrity is embedded in all site activities and that Regulatory and Global Quality requirements cascade to site functions.

The role focuses on data quality checks, training, risk assessment, CAPAs, documentation, and supporting regulatory inspections and audits, including DIMM reporting; candidates should have at least 2 years in a regulated environment.

Competenze

• 2 years working experience in a regulated environment.
• Knowledge of data integrity principles and practices.
• Familiarity with CAPA and regulatory inspections.

Mansioni

• Ensure data integrity is embedded in all site activities.
• Perform data quality checks and validations.
• Develop and deliver data integrity training programs.
• Identify and mitigate data integrity risks.
• Maintain documentation practices for data recording, storage and retrieval.
• Lead investigations into data integrity incidents and implement CAPAs.
• Support regulatory inspections and audits related to data integrity.
• Monitor and report on Data Integrity metrics (e.g., DIMM).

Conoscenze

Data integrity

Regulatory compliance

Quality systems

Training development

Descrizione del lavoro

A Data Integrity Specialist is required for a biopharmaceutical company in Waterford. The successful candidate will ensure that Data Integrity is embedded in all aspects of work performed onsite and ensure that Regulatory and Global Quality requirements are cascaded to site functions to ensure that all Data Integrity requirements are met.

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.

Qualifications & Experience:

• 2 years working experience in a regulated environment.