Senior Data Integrity Specialist

Senior Data Integrity Consultant required for a major Bio tech CAPEX(Capital  Expenditure)project in the North of England.

Working on this major investment from inception ,the Senior Data Integrity Specialist will be responsible for interfacing with varied project stakeholders across Quality and Engineering teams from design stage throughout the entire project life cycle ensuring corporate and regulatory standards are met across Building and Automation systems, process equipment within upstream and downstream manufacturing and QC Laboratories.


The Consultant will be responsible for the following.

• DI (Data Integrity GAP analysis and assessment ( Complete periodic DI audits across the site)
• Strategy division in unison with existing departmental Leads and corporate/ site strategy.
• Ensure that all project milestones for DI are met
• DI assessment process implementation and coaching/ mentoring in multidisciplinary teams.
• Manage change execution for DI related changes
• Lead business process design efforts relating to project DI (Data Integrity) solutions
• Support DI training on site as required to up skill and increase DI awareness
• Development and leadership of a governance structure to allow for sponsorship and partnership of the site Senior leadership team and corporate.
• Participate in additional training on data integrity and industry requirements as required
• Lead communications to the sustaining sponsors, senior leadership and department leadership teams as appropriate.

 

Requirements

• Significant projects-based Data Integrity Leadership or implementation experience
• Extensive 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
• Knowledge of relevant regulatory requirements for DI, including GMPs
• Skilled Change Manager
• Planning and Scheduling
• Strong DI/IT knowledge/abilities

 
Please apply now for this unique opportunity to join a major UK based CAPEX investment with 2 years work available. 
 



The candidate must have the rights to work in the location stated in the job advert.

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