- The Data Integrity Specialist will represent the site Quality Assurance department as SME in Data Integrity
- Co-ordinate the Data Integrity activities for all systems for Manufacturing, Laboratory, Manufacturing and IT areas.
- Lead business process design efforts relating to Data Integrity solutions and chair the site Data Integrity council
- Track and provide Data Integrity metrics to Quality Management on a regular basis
- The Data Integrity Specialist will manage the site Quality Risk Register and associated activities
- Perform Data Integrity risk assessment of all GMP documentation systems and support stakeholders in the mitigation of DI risks.
- Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9,Q10, GAMP5 and all applicable regulatory requirements
- Participate as Site DI SME on Veritas Project forums and working groups
- Ensure alignment between the local and global data management and controls program efforts
- Represent Site in regulatory audits related to Data Integrity
- Establish a firm understanding of IT Infrastructure, assesses proposed changes for Data integrity implications, and recommends infrastructure changes to enhance Data Integrity
- The Data Integrity Specialist will evaluate proposed and existing software systems that support manufacturing, warehousing and laboratory and also software applications for Data Integrity gaps. Works with IT and QA to resolve those gaps
- Write or review and approve protocols, reports and SOP’s to effect DI gap remediation as appropriate
- Initiate action reports or deviation reports for any applicable nonconformance
- Seek process innovation and continuous process improvements
- The next Data Integrity Specialist should have a third level qualification in Science, Engineering or related discipline, preferably a bachelor’s degree with 5+ years industry experience including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
- Experience in technical and compliance requirements for validating IT systems in accordance with regulatory Data Integrity controls including 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all applicable regulatory requirements
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