✓Seeking a Quality Engineer / Technical Writer due to further growth and expansion plans at a client's facility in Limerick
✓The Quality Engineer will be supporting scientific and laboratory services, including multivendor instrument, information technology, and validation/compliance services, and working seamlessly with the lab computing environment
✓* Technical writing of IT Deviations, CAPAs, Change Controls, SOPs and other Departmental/System Quality Documents in compliance with regulatory and corporate requirements
✓* Assist IT personnel in technical writing/responding to CAPAs [including remediation activities], Change Controls, SOPs and other Departmental/System Quality Documents in compliance with regulatory and corporate requirements
✓* Assists IT personnel in technical writing/responding to Deviation/Events including detailed event investigation and root cause analysis in compliance with regulatory and corporate requirements
✓* Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System.
✓* Successfully navigate the Electronic Quality Management System and work with other impacting departments to ensure IT Deviations, CAPAs, Change Controls, SOPs, etc are monitored, progressed and closed in-line with agreed timelines
✓* Assists IT personnel in participating in and successfully navigating through the electronic Quality Management Processes
✓* Represents IT at meetings relating to assigned items
✓* Assists IT SME's during internal and external audits
✓Knowledge and Skills:
✓* Excellent technical writing ability and communication skills
✓* Knowledge and experience of working in a cGMP regulated environment
✓* Excellent attention to detail, computer skills, and ability to adapt to new systems/technologies
✓* Ability to work independently with only high level guidance and supervision
✓If you are interested in IT Lab instrumentation and equipment related roles in Limerick over the coming months then please apply to this role.
✓Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.
✓Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO [UK] Limited, Marks Sattin [UK] Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited
✓We are committed to protecting the privacy of all of our candidates and clients
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