Quality Excellence

2 days ago

Ireland, India GE Healthcare Ltd Full time € 60,000 - € 1,20,000 per year
Job Description

Summary

The Quality Excellence & Process Analytics Lead will be responsible for managing GMP documentation systems, coordinating quality records within the QC department, and supporting data-driven process analytics including Continued Process Verification (CPV). This role ensures compliance with regulatory standards, drives documentation excellence, and supports quality investigations, CAPAs, and change control processes. The position plays a key role in maintaining data integrity and enabling continuous improvement across quality control systems.

Responsibilities:
  • Lead and maintain controlled documentation systems including SOPs, validation protocols/reports, CPV plans, and technical documentation.
  • Oversee the management and compliance of quality records generated within the QC department, including test data, investigations, and audit trails.
  • Coordinate and support the lifecycle of Change Controls, CAPAs, and Quality Investigations, ensuring timely closure and regulatory compliance.
  • Analyse QC data to support CPV activities and identify trends, risks, and improvement opportunities.
  • Ensure documentation and records meet regulatory requirements (EU GMP, FDA, ICH) and internal quality standards.
  • Collaborate cross-functionally to support validation, investigations, and audit readiness.
  • Develop and maintain dashboards or reports to visualize trends in process and QC data.
  • Participate in internal and external audits, providing documentation and technical support.
  • Promote data integrity and continuous improvement across documentation and analytics processes.
  • Train and mentor team members on documentation best practices, investigation writing, and data analysis tools.
Qualifications
  • Bachelors or masters degree in a scientific or engineering discipline (e.g., Chemistry, Biotechnology, Pharmaceutical Sciences).
  • Solid experience in a GMP-regulated environment, with exposure to QA, QC, and validation.
  • Strong understanding of CPV principles, quality documentation systems, and laboratory data lifecycle.
  • Experience coordinating CAPAs, change controls, and investigations in a regulated environment.
  • Proficiency in data analysis tools (e.g., Excel, Minitab) and electronic quality systems (e.g., Trackwise, Veeva, LIMS).
  • Excellent organizational, analytical, and communication skills.
Preferred Skills
  • Experience with statistical process control (SPC) and trending methodologies.
  • Familiarity with regulatory guidelines (ICH Q10, FDA PV guidance).
  • Knowledge of QC testing workflows and data lifecycle.
  • Experience in leading cross-functional quality improvement initiatives.
Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

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Additional Information

Relocation Assistance Provided: No
Locations: Cork, Cork, Ireland, T45 AV60

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