Data Integrity Specialist

• Responsible for the development and support of a DI Query/Issue Tracking system
• Track Issues and assign response criticality
• Define initial metrics by which compliance to DI will be measured (in line with project progress) and collation of metrics for presentation to SLT
• Assist the business with Data Mapping including instruction on ALCOA Worksheet use and map generation
• Support Data Integrity (DI) activities at Biotech Dublin for all systems – Laboratory, Manufacturing and IT
• Assist in planning process for periodic audit trail review of systems
• Complete periodic DI audits across the site
• Work with the business to determine frequency and details associated with Audit Trail Review

• Planning and Scheduling
• DI Experience of standalone, networked, hosted and SAAS solutions
• Demonstrated problem solving skills
• Understanding of system Risk Register and Risk Management principles
• Continuous improvement skills
• Assertive, strong communicator

• A minimum of 5 years’ experience in a pharmaceutical environment.
• A minimum of 2 years’ Quality experience
• Knowledge of relevant GMP and DI standards
• Deep understanding of current regulatory requirements and expectations
• Validation of IT systems
• Auditing of IT systems
• Strong scientific understanding
• Knowledge of relevant regulatory requirements for DI, including GMPs

• Ability to interact with multiple stakeholders across numerous departments
• Ability to work independently and as part of a team. 
• Excellent communication skills and the ability to work in a cross functional collaborative environment. 

 
Education

BSc. (or equivalent experience base) in Science/Engineering or a related discipline.

Please apply now for more information. 

With Kind Regards / Met Vriendelijke Groeten / Mit freundlichen Grüßen / Meilleures salutations,