Technical Writer

at  SL Controls Ltd

SKILLS BRIEF:

• Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards,GAMP5, and Documentation Management/Life Cycle guidance
• Applies 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.BS/BA in Life Sciences, Engineering, English or related field or equivalent combination of education and experience.

THE ROLE:

• Technical Writer
• Limerick – Onsite
• Permanent or Contract Opportunity

ROLE BRIEF:

Perform all technical writer related tasks necessary for the creation and maintenance of quality GMP documentation in support of the Technical Operations Engineering and Automation Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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)
• Perform retrospective assessment of computerized system administration activities and author the resulting reports.
• 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.
• Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.
• Conduct compliance review of electronic work tickets for adherence to GoodDocumentation Practices/Requirements
• Facilitate cross-functional collaboration of cGMP documentation with technical experts and stakeholders to reach consensus and ensure document approval timelines meet business needs.
• Own and/or support GMP document-related Change Controls/CAPAs.