Biopharma Data Integrity Architect

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

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.