CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
We are now seeking a Quality Control IT Technician with a strong focus on technical writing to join our growing operations in Ireland. In this role, the Quality Control IT Technician will support Quality Control by ensuring compliance with data integrity (DI) and IT standards throughout all documentation and equipment qualification activities; assist in the preparation, review, and management of technical documents related to IT systems and data integration; develop and maintain clear procedures for data handling, system validation, and IT processes; review and verify Test Outlines and Procedures (TOPs) for IT systems; help coordinate IT system qualification activities; prepare and maintain Qualification Summary Reports (QSRs) and other documentation to track compliance with quality and DI standards; conduct reviews of system Design Evaluations, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify quality outcomes for IT systems; manage QC processes related to IT qualifications, including document control, change controls, and oversight of DI compliance; collaborate with IT project teams, contractors, and vendors to execute and validate testing; allocate resources and support the organization of documentation and materials needed to meet QC and IT deliverables; provide quality assurance support throughout IT system qualification, ensuring that all documentation meets regulatory and DI requirements.
Position Requirements
* BS or MS in a relevant science or engineering field, or equivalent experience.
* 3+ years of industry related experience
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
* Excellent problem-solving skills with a Quality Control mindset.
* Strong customer-service orientation.
* Proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or with equivalent experience.
* Willing and able to travel domestically and internationally, if required.
€35,000 - €80,000 a year
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
* Industries
* Pharmaceutical Manufacturing
Limerick, County Limerick, Ireland
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