Technical Writer

Quality Engineer
Limerick
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
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.