Job Description
An experienced Technical Writer is required to collaborate with our biotech client in Limerick.
Key Responsibilities
* Collaborate with subject matter experts to develop and maintain GMP documents, including standard operating procedures, system design documents, and work instructions.
* Perform retrospective assessments of computerized system administration activities and author reports.
* Review and improve internal GMP documents to ensure compliance with site document requirements, document control procedures, and good documentation best practices.
* Manage document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.
* Conduct compliance reviews of electronic work tickets for adherence to Good Documentation Practices/Requirements.
Requirements
* Bachelor's degree in Life Sciences, Engineering, English or related field.
* 5 years of relevant experience or equivalent combination of education and experience.
* Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance.
* Excellent writing and proofreading skills in a technical and scientific capacity.