Technical Writer
PerkinElmer
- Limerick
- Permanent
- Full-time
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- Technical writing of IT Deviations, CAPAs, Change Controls, SOPs and other Departmental/System Quality Documents
- Assist IT personnel in technical writing/responding to CAPAs (including remediation activities), Change Controls, SOPs and other Departmental/System Quality Documents
- 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.
- Navigate the Electronic Quality Management System and work with other impacting departments to assist with monitoring, progressing and closing applicable IT Deviations, CAPAs, Change Controls, and SOPs
- Assists IT personnel in participating in and navigating through the electronic Quality Management Processes
- Assists IT SME's during internal and external audits. Regeneron is responsible for all responses to any such audit requests.
- Bachelor degree or equivalent relevant experience
- Previous CGMP regulated environment
- Experience in root cause analysis and investigations
- QA Technical writing experience
- MS Office
- Change control system experience eg Trackwise, document management systems or similar
- GXP pharmaceutical experience
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