Our site in Waterford, Ireland is looking for an experienced Data Integrity Specialist.
The Data Integrity Specialist will assess, develop strategies, implement processes/controls as part of the Quality Assurance team, and ensure compliance with all ISO 13485 data integrity requirements.
Key Responsibilities and End Results: Working with cross-functional teams to define and support electronic data systems projects and initiatives. Harmonizing the use and management of electronic data systems across the different areas of the site. Contributing to global projects aimed at data systems. Reviewing updates to regulatory guidelines for electronic data systems to ensure ongoing compliance. Coordinating the needs of functional areas and establishing priorities for electronic data systems including gap analysis and remediation programs. Working with the IT, Automation, and NPI groups on projects such as defining User Requirement Specifications and executing test plans. Providing support for computerized systems. Providing training and support on Data Integrity across the site. Writing and revising Standard Operating Procedures (SOPs). Reviewing documents to ensure consistency with SOPs and current formats. Ensuring data integrity gap analysis are complete for all systems and equipment on site both new and already in use to ensure compliance. Developing remediation plans/strategies if required for systems in use. Developing a data integrity program for the site and being the site point of contact for all audits. Ensuring continuous improvements are in place for Data Integrity. Completing gap analysis and putting solutions in place using a risk-based approach. Supporting all company safety and quality programs and initiatives. Ensuring ongoing compliance with GMP in all practices, recording of events and processes. Ensuring compliance with all learnings from all GMP training events. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position. Requirements: Bachelor's degree in information technology or relevant discipline. Min of 2 years' experience of implementing Data Integrity related controls in an Information Technology and Operational Technology environment. Extensive knowledge about Data Integrity related regulations. Skills & Attributes: Excellent accuracy and attention to detail. Excellent communication and interpersonal skills to communicate well, both verbally and in writing. Excellent initiative, decision-making, and the ability to work in a core team environment. Excellent time management skills. Desire to learn new tasks and flexibility. Solution-driven with emphasis on performance and results. The Data Integrity Specialist reports to the Quality Lead.
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