Quality Control Specialist

at  GE Healthcare

JOB DESCRIPTION SUMMARY

In this role you will provide technical support to QC, QA and Operations regarding LIMS and MODA. You will ensure the LIMS and MODA systems are compliant, remain in a validated state and are operating in a manner to allow QC, QA and Operations complete their respective activities with no negative impact to batch release. The position involves carrying out and co-ordinating LIMS and MODA activities with regard to the control of all Chemistry, Microbiology, Stability, Water and Environmental Monitoring. For this role you will work onsite at our production site in Cork on a 12-month contract.

JOB DESCRIPTION

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.
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 ~700 staff and are a 24/7 operation exporting to 93 markets worldwide. 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, quality, and compliance to patients around the world and are on a transformation journey to double our capacity over the next 5 years.

BASIC REQUIREMENTS

• Degree in Science, Computer or equivalent combined with relevant experience in the pharmaceutical or related industry
• Experience with LIMS
• Strong communication skills.

• Act as a technical and compliance liaison with QC, Operations and QA
• Maintain and update global LIMS according to established change procedures: TrackWise change controls, SOP’s, harmonisation across sites and Periodic review ensuring timely closure.
• Assist in the testing and validation of Disaster Recovery procedures
• Liaise with other LIMS Admins, laboratory supervisors and global IT regarding changes and system improvements to achieve efficiencies
• Troubleshoot all LIMS and MODA issues to ensure no delay to batch release
• Write and execute test scripts to validate LIMS and MODA master data and reports
• Familiar with 21 CFR part 11 and data integrity and how it applies to LIMS and MODA
• Support/co-ordinate training of new LIMS and MODA users. Roll out training of procedural updates and provide ongoing support to LIMS and MODA users.