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OneSource Technical Writer

Limerick Ireland

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Responsibilities

Location Limerick, IE Job ID REQ-050247

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 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.

Qualifications & experience required:

  • 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

Other advantageous experience:

  • GXP pharmaceutical experience

Please note this is a site based role.

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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