QA Data Integrity Specialist
- The Data Integrity specialist will represent the site QA 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
- 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.
- Prioritize risks and work with all site departments to ensure documentation compliance
- Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with all applicable regulatory requirements
- Ensure alignment between the local and global data management and controls program efforts
- 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.
- Assure all systems, processes and their outcomes comply with standards, regulations and guidelines.
- 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
- Recognize and report to immediate supervisor any issues or deviations from accepted standards
- Provide status updates on own activities and productivity challenges according to defined procedures
- The Data integrity specialist will have a BSc in a related discipline.
- They will have 5 years experience working in a relevant GMP industry where 3 years of thats experience is in a computer systems validation or QA role with relevant CSV experience.
- Experienced 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
8% annual bonus, pension, healthcare.
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