Job Description Summary

Job Description

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 ofChange ControlsCAPAs andQuality Investigations ensuring timely closure and regulatory compliance.

• Analyse of 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