QC Graduate - Computer Systems

at  GE Healthcare

JOB DESCRIPTION SUMMARY

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GENERAL DESCRIPTION:

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.
Every second of every day, 365 days a year, a patient is diagnosed with the help of 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, compliance, and quality to patients around the world.
You will provide IT support for QC Instrumentation and software projects introduced by the digital lab team.
The ideal candidate will possess a strong blend of technical expertise and a strategic mindset to drive the development and implementation of cutting-edge digital solutions.

QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:

• You have achieved a Professional Level 8 qualification.
• Experience in a GMP regulated environment preferable.
• You are a confident decision maker, an effective planner, and an effective communicator with strong leadership skills.
• Customer focused, strong analytical and problem-solving ability.
• Ability to prioritize, demonstrating good time management skills.
• Proven communication skills and collaboration within a team.
• Understanding of IT infrastructure, systems, and technologies, including networks, databases, servers, and operating systems relevant to lab systems.

MAIN DUTIES & RESPONSIBILITIES:

Performance

• Execution of digital projects, ensuring timely delivery, budget adherence and quality output. Collaborate with cross-functional teams to meet project objectives.
• Provide technical guidance to project teams on the development of digital lab projects ensuring the IT/ computer system scope of work is accurate and complete.
• Liase with vendors on system details to support the development of project scope specific to IT/ computer systems.
• Support the generation of project metrics and report outs to ensure clear communication to stakeholders of key performance measures including scope, schedule, cost, and quality.
• Collaborate and engage with all QC functions and other departments to understand business needs and incorporate into project designs.
• Data collection and feasibility assessment for projects for the development of a robust business case outlining clear deliverables, benefits measured against a laboratory baseline.
• Authoring and reviewing of project documentation inclusive of QMS, validation and project management documents.
• Troubleshoot lab system issues within digital projects ensuring operations is not impacted and issues are resolved or escalated.
• Write and execute test scripts to validate LIMS and MODA updates introduced with digital lab projects.
• Work with LIMS and MODA Admins, IT team/vendor/ LIMS/MODA support to increase working knowledge of LIMS and MODA to develop future system upgrades/ projects.
• Continuous improvement planning related to lab systems and implement instrument interfacing within the scope of digital labs.
• Familiar with 21 CFR part 11 and data integrity and how it applies to LIMS and MODA.

Compliance, EHS & Quality

• Adherence to Systems, Policies and procedures in place to ensure maintenance activities are carried out in compliance with Environmental, Safety, Health, Good Engineering Practice, and other corporate standards and regulations.
• Responsibility for generation and maintenance of validation documentation related to digital projects/ projects in scope of the digital lab/ LCM team and ensuring these meet regulatory requirements.
• Performing QC/ Validation activities in compliance with product licence commitments, cGMP and company Quality standards in relation to projects in scope of the digital lab/ LCM team.