CSV & Data Integrity Lead: Regulatory Systems Expert

MS0234 GE Healthcare Ireland Limited

Cork

On-site

EUR 110,000 - 140,000

Full time

14 days+

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Job summary

GE HealthCare is seeking a Computerized Systems Validation (CSV) & Data Integrity Lead for our Cork, Ireland site. You will own and continually improve CSV and Data Integrity frameworks, acting as site SME for compliance with GxP requirements and regulatory inspections.

You will collaborate with Engineering, Quality, Manufacturing, IT and suppliers to ensure lifecycle management of computerized systems. Reporting to the Automation Manager, you will drive risk-based validation, CSA practices,

Qualifications

Relevant degree in Engineering, Computer Science, Life Sciences or related discipline.
Significant experience with Computerized Systems Validation in regulated environments.
Strong knowledge of ALCOA+ Data Integrity principles and regulatory expectations.
Experience with validation documentation packages and lifecycle activities.

Responsibilities

Own and continuously improve CSV and Data Integrity procedures, standards, templates and governance processes.
Maintain and periodically review the site inventory of GxP computerized systems.
Ensure computerized systems validation activities are performed in accordance with site procedures, regulatory requirements and industry best practice.
Work closely with Engineering, Quality, Operations, IT and external vendors to ensure validation deliverables meet site and regulatory requirements.
Develop and approve validation strategies, validation plans, risk assessments, requirements specifications, test protocols and validation summary reports as required.
Ensure appropriate application of Computer Software Assurance (CSA) and risk-based validation methodologies.
Maintain Requirements Traceability Matrices and Data Lifecycle documentation for applicable systems.
Lead Data Integrity assessments, gap analyses and continuous improvement initiatives.
Promote compliance with ALCOA+ principles and Data Integrity requirements across site functions.
Ensure appropriate change management processes are followed for computerized system introductions, upgrades and modifications.
Develop and execute Change Controls and TrackWise records for computerized systems where required.
Review and approve vendor validation documentation and ensure supplier deliverables satisfy site requirements.
Support and attend Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), commissioning and qualification activities as required.
Lead or support periodic reviews to ensure computerized systems remain in a validated state.
Monitor developments in regulations and industry guidance including Annex 11, 21 CFR Part 11, GAMP 5, Data Integrity Guidance and CSA practices.
Maintain awareness of evolving regulatory and industry expectations & best practices and ensure timely implementation into site procedures and practices.
Serve as SME during regulatory inspections, customer audits and internal audits.
Support audit preparation activities and lead responses to computerized system and Data Integrity observations.
Provide technical leadership and mentoring to Engineering, Automation, Quality and Operations personnel in CSV and Data Integrity best practices.
Work collaboratively to ensure key commitments, project milestones and compliance objectives are achieved.