Technical Writer

1 month ago

Limerick, Ireland PerkinElmer Full time

PerkinElmer is looking for an additional Technical Writer to join the small team based on our client's site in Raheen, near Limerick.

The team support R&D lab managers with all aspects of compliance documentation in particular: document control, change control and writing deviations of IT systems.

This is an FDA audited site so regulations include 21CFR Part 11.

Responsibilities:

Technical writing of IT Deviations, CAPAs, Change Controls, SOPs and other Departmental/System Quality DocumentsAssist IT personnel in technical writing/responding to CAPAs (including remediation activities), Change Controls, SOPs and other Departmental/System Quality DocumentsAssists IT personnel in technical writing/responding to Deviation/Events including detailed event investigation and root cause analysis in compliance with regulatory and corporate requirementsAssists 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 SOPsAssists IT personnel in participating in and navigating through the electronic Quality Management ProcessesAssists IT SME’s during internal and external audits. Regeneron is responsible for all responses to any such audit requests.

Qualifications & experience required:

Bachelor degree or equivalent relevant experiencePrevious CGMP regulated environmentExperience in root cause analysis and investigationsQA Technical writing experienceMS OfficeChange control system experience eg Trackwise, document management systems or similar

Other advantageous experience:

GXP pharmaceutical experience

Please note this is a site based role.

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