QA Specialist / Qualified Person (QP)

Job Description Summary

As the QA Specialist/QP, you will manage and drive the site QA systems in close cooperation with other specialists in the QA Quality team. You will coordinate and execute all QA duties relating to QP batch release and communicate all issues.

GE HealthCare Ireland Limited manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE Healthcare, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. Here at our campus at Carrigtwohill, Co. Cork, we employ over 650 staff and are a 24/7 operation exporting to over 100 markets worldwide.
Every second of every day, 365 days a year, a patient is diagnosed with the help our products through procedures such as X-Ray and MRI. We are a modern, agile, cost competitive team delivering to the highest standards of safety, quality and compliance to patients around the world and are on a transformation journey to double our capacity over the next 5 years.

Job Description

Responsibilities 

• Coordination of the certification of finished product batches to the market as required under the EU directive 2001/83/EC

• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing Authorization

• Maintain oversight of deviations, CAPA & change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required

• Continuous improvement of the manufacturing and quality systems – identifying and building in efficiencies as necessary from a systematic and compliance perspective

• Provide support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business needs

• Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.

Qualifications and experience

• 3rd level qualification in Science / Engineering discipline or equivalent knowledge or experience

• Significant experience within a GMP / QA environment in a pharmaceutical company or similar regulated environment

• Eligible to act as a Qualified Person in line with local and EU directives.

Desired Skills

• Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization

• Excellent communication, negotiation and risk-based decision-making skills, promoting openness, dialogue and collaboration

• Results oriented with a strong ability to effectively troubleshoot, and problem solve issues

• Promote a continuous improvement culture.

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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information