Technical Writer - PE Global
  • Limerick, Munster, Ireland
  • via BeBee.com
-
Job Description

Technical Writer sought for 12-month contract role in Limerick, Ireland, to create and maintain quality GMP documentation for a pharmaceutical client.

Collaborate with subject matter experts to develop and maintain GMP documents, including standard operating procedures, system design documents, and work instructions.

Key Responsibilities:

  • Collaborate with subject matter experts to ensure timely development and accurate content of GMP documents.
  • Perform retrospective assessment of computerized system administration activities and author resulting reports.
  • Maintain awareness and understanding of current site document requirements, document control procedures, and good documentation best practices.
  • Review internal GMP documents to ensure compliance with expectations and suggest improvements.
  • Manage and coordinate activities related to document creation using the Electronic Document Management System.
  • Conduct compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements.
  • Facilitate cross-functional collaboration of c GMP documentation with technical experts and stakeholders.
  • Own and/or support GMP document-related Change Controls/CAPAs.

Requirements:

  • Associate Technical Writer: BS/BA in Life Sciences, Engineering, English or related field or equivalent combination of education and experience.
  • Technical Writer: BS/BA in Life Sciences, Engineering, English or related field and 2 years of relevant experience or equivalent combination of education and experience.
  • Senior Technical Writer: BS/BA in Life Sciences, Engineering, English or related field and 5 years of relevant experience or equivalent combination of education and experience.

Knowledge, Skills, and Abilities:

  • Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance.
  • Excellent collaboration skills, via multiple communication types, in a steady-paced environment.
  • Strong writing and proofreading skills in a technical and scientific capacity.
  • Ability to organize and author technically complex information into laymen suitable documentation.
  • Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes.

;