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Senior Technical Writer

  1. East
County Limerick
  1. Contract
Competitive
  1. Life Sciences
22-04-2024
33947

This vacancy has now expired

Senior Technical Writer - Pharmaceuticals - 12-Month Contract 

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.


Role Summary:
  • 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 computerised 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. 
 

Education and Experience
  • Associate Technical Writer Requires BS/BA in Life Sciences, Engineering, English or 
  • related field or equivalent combination of education and experience. 
  • Technical Writer: Requires 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: Requires BS/BA in Life Sciences, Engineering, English or related field and 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
  • 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 organise 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.

If this role is of interest to you, please apply now! 

 #LI-CH3
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