Job Description
An experienced Technical Writer is required by Careerwise recruitment to work with our Limerick based biotech client.
Role of this position
1. Collaborate with subject matter experts and key functional department personnel to ensure timely development and accurate content of GMP documents (e.g. standard operating procedures, system design documents, and work instructions).
2. Perform retrospective assessment of computerized system administration activities and author the resulting reports.
3. Maintain an awareness and understanding of current site document requirement, document control procedures, and good documentation best practices. Review internal GMP documents to ensure they are compliant with these expectations and suggest improvements.
4. Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.
5. Conduct compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements.
JOB REQUIREMENTS
6. BS/BA in Life Sciences, Engineering, English or related field.
7. 5 years of relevant experience or equivalent combination of education and experience.
8. Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance.
9. Strong writing and proofreading skills in a technical and scientific capacity.