Job Description Summary
This is an opportunity for a skilled QA Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.
As part of our vision for our manufacturing campus in Cork – of becoming a 50m to 60m unit (vials) capacity parametric release site – we're set to introduce a new filling line.
Reporting to our Value Stream Quality Leader, you'll manage the site's QA systems alongside other specialists in the QA Product Quality team.
In particular, your role will involve coordinating and executing all QA duties for the QP batch release, ensuring that we continue to deliver life-changing equipment to patients across the globe.
Responsibilities
Ensure compliance with GMP, GE Healthcare Corporate Standards, Quality Management System (QMS), site policies, procedures, regulatory requirements and industry standards.
Partner closely with customers and stakeholders to understand and deliver on all activities within timelines, escalating when necessary.
Lead and support cross-functional/continuous improvement teams to provide consultative and collaborative support on quality-related issues.
Lead and support investigation of root causes and resolution, ensuring appropriate CAPA actions are implemented to prevent recurrence where relevant.
Author, track, manage change, review/approve/authorise relevant documentation types including SOPs, investigations, regulatory commitments, audit documentation, change controls, forms, logbooks, QC stability program, validation and batch release documentation.
Lead and support management of relevant metrics and forums to ensure ownership and delivery of, and compliance with, key site metrics.
Qualifications and Experience
A degree-level qualification in Science/Engineering discipline or equivalent knowledge and experience.
Previous relevant quality experience within a QA/QC GMP environment in the pharmaceutical industry.
Excellent communication and interpersonal skills.
Ability to work independently and collaboratively within a dynamic, fast-paced environment.
Desired Skills
Ability to create and maintain effective interpersonal relationships with all levels of personnel in cross-functional departments.
Excellent communication, negotiation and risk-based decision-making skills, promoting openness, dialogue and collaboration.
Results-oriented with a strong ability to troubleshoot and problem-solve issues.
Promotion of a continuous improvement culture.
Eligibility Requirements
Good level of English and a valid work permit.
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.
Benefits
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.
We offer opportunities for career growth within a culture that fosters care, collaboration and support.
Additional Information
Relocation assistance provided: No.
At GE HealthCare, we see possibilities through innovation.
We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions.
Together, we are building a healthier future and living our purpose to create a world where healthcare has no limits.
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