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Job Description
Technical Writer needed for 12-month contract role in Limerick, Ireland, to create and maintain quality GMP documentation for a pharmaceutical company.
As a Technical Writer, you will collaborate with subject matter experts to develop and maintain GMP documents, including standard operating procedures, system design documents, and work instructions. You will also perform retrospective assessments of computerized system administration activities and author reports.
Key responsibilities include:
- Collaborating with subject matter experts to ensure timely development and accurate content of GMP documents
- Performing retrospective assessments of computerized system administration activities and authoring reports
- Maintaining awareness of current site document requirements, document control procedures, and good documentation best practices
- Managing and coordinating activities related to document creation using the Electronic Document Management System
- Conducting compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements
- Facilitating cross-functional collaboration of cGMP documentation with technical experts and stakeholders
- Supporting 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
Key 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 layman suitable documentation
- Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes
Interested candidates should submit an updated CV.