Responsibilities:
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.
Qualifications and experience:
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
Technical:
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
Education:
BSc. (or equivalent experience base) in Science/Engineering or a related discipline.
