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 and key functional department personnel 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.