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 Good
Documentation 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.