Interpretation of worldwide industry regulations related to use, 21 CFR Part 11, Data Integrity and validation, and ensuring that appropriate policies, SOP’s and procedures are implemented and maintained Ensuring that quality-critical computer systems are appropriately validated Ensuring that sites and support organisations are ready for regulatory inspections Accountable/responsible for the following functions: Conducting assessments of computerised systems, corporate IT projects/infrastructure for compliance with company and regulatory computer validation requirements including 21 CFR Part 11 Reviewing and approving computer system validation documentation Managing the ongoing compliance monitoring of strategic, business-critical IT systems in order to provide formal QA approval Monitoring compliance and progress with internal audit and regulatory inspection Observations Communicating results of site, corporate project assessments and regulatory inspections to senior management Providing sites and IT Projects with technical support before, during and after regulatory and internal inspections Ensuring staff are trained in computer system validation and Inspection Readiness Prioritising and providing technical support/guidance for validation of specific computer systems Providing support for adoption of and compliance with the global Project Management Methodology and CSV policies and procedures Contributing to development of departmental and corporate policies, procedures and SOP’s Essential role requirements: Consultancy and auditing skills; negotiation skills; ability to train and delegate work to other staff; staff management; ability to communicate clearly and effectively in written and oral form to all levels within the company Demonstrated ability to be a team player and to work independently whilst keeping direct manager informed of significant issues; well-developed decision making ability
Listed skills include Computer System Validation, 21 Cfr Part 11, Quality Assurance, Change Control, and 6 others.