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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